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    Clinical Trial Results:
    A phase I-Ib/II, open-label, multi-center study of the safety and efficacy of MBG453 as single agent and in combination with PDR001 in adult patients with advanced malignancies

    Summary
    EudraCT number
    		 2015-002354-12
    Trial protocol
    		 NL   DE   IT  
    Global end of trial date
    30 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Sep 2023
    First version publication date
    13 Sep 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CMBG453X2101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02608268
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of the trial were: Phase I-Ib parts: • To characterize the safety and tolerability of MBG453 as a single agent in rest of the world (ROW) and Japanese patients separately and in combination with PDR001 and to identify recommended doses for future studies. • To characterize safety and tolerability of MBG453 in combination with decitabine and identify recommended dose for future studies. Phase I-Ib dose ranging part: • To further investigate the safety and tolerability of different doses of MBG453 as single agent or in combination with PDR001. Phase II part: • To estimate the anti-tumor activity of MBG453 as single agent and in combination with PDR001 or in combination with decitabine.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2015
    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
    Canada: 11
    Country: Number of subjects enrolled
    Italy: 50
    Country: Number of subjects enrolled
    Japan: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Netherlands: 31
    Country: Number of subjects enrolled
    Singapore: 22
    Country: Number of subjects enrolled
    Switzerland: 28
    Country: Number of subjects enrolled
    Taiwan: 18
    Country: Number of subjects enrolled
    United States: 68
    Worldwide total number of subjects
    252
    EEA total number of subjects
    81
    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)
    154
    From 65 to 84 years
    97
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants took part in 14 investigative sites in 9 countries.

    Pre-assignment
    Screening details
    		 The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 28 days prior to the first dose of study medication. After screening, the treatment period started on Cycle 1 Day 1.

    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
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW
    Arm description
    		 Sabatolimab 80 mg every 2 weeks (Q2W) in Phase I Dose Escalation Part in rest of the world (ROW) patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 80 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 240mg Q2W ROW
    Arm description
    		 Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in ROW patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 800mg Q2W ROW
    Arm description
    		 Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in ROW patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 1200mg Q2W ROW
    Arm description
    		 Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in ROW patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 1200 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 80mg Q2W Japan
    Arm description
    		 Sabatolimab 80 mg Q2W in Phase I Dose Escalation Part in Japanese patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 80 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 240mg Q2W Japan
    Arm description
    		 Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in Japanese patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 800mg Q2W Japan
    Arm description
    		 Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in Japanese patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 1200mg Q2W Japan
    Arm description
    		 Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in Japanese participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 1200 mg every 2 weeks (Q2W)

    Arm title
    		 Phase I Dose Escalation: MBG453 240mg Q4W ROW
    Arm description
    		 Sabatolimab 240 mg every 4 weeks (Q4W) in Phase I Dose Escalation Part in ROW patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg every 4 weeks (Q4W)

    Arm title
    		 Phase I Dose Escalation: MBG453 800mg Q4W ROW
    Arm description
    		 Sabatolimab 800 mg Q4W in Phase I Dose Escalation Part in ROW patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg every 4 weeks (Q4W)

    Arm title
    		 Phase I Dose Escalation: MBG453 1200mg Q4W ROW
    Arm description
    		 Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in ROW patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 1200 mg every 4 weeks (Q4W)

    Arm title
    		 Phase I Dose Escalation: MBG453 1200mg Q4W Japan
    Arm description
    		 Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in Japanese patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 1200 mg every 4 weeks (Q4W)

    Arm title
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W
    Arm description
    		 Sabatolimab 20 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 20 mg Q2W in combination with spartalizumab 80 mg Q2W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W
    Arm description
    		 Sabatolimab 80 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 80 mg Q2W in combination with spartalizumab 80 mg Q2W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W
    Arm description
    		 Sabatolimab 240 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg Q2W in combination with spartalizumab 80 mg Q2W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W
    Arm description
    		 Sabatolimab 240 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg Q2W in combination with spartalizumab 240 mg Q2W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W
    Arm description
    		 Sabatolimab 800 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg Q2W in combination with spartalizumab 80 mg Q2W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W
    Arm description
    		 Sabatolimab 800 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg Q2W in combination with spartalizumab 240 mg Q2W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W
    Arm description
    		 Sabatolimab 80 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 80 mg Q4W in combination with spartalizumab 80 mg Q4W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W
    Arm description
    		 Sabatolimab 80 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 80 mg Q4W in combination with spartalizumab 400 mg Q4W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W
    Arm description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg Q4W in combination with spartalizumab 80 mg Q4W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W
    Arm description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 240 mg Q4W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg Q4W in combination with spartalizumab 240 mg Q4W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W
    Arm description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg Q4W in combination with spartalizumab 400 mg Q4W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W
    Arm description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W

    Arm title
    		 Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W
    Arm description
    		 Sabatolimab 1200 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 1200 mg Q4W in combination with spartalizumab 400 mg Q4W

    Arm title
    		 Dose Ranging Part: MBG453 80mg Q4W
    Arm description
    		 Sabatolimab 80 mg Q4W in Dose Ranging Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 80 mg every 4 weeks (Q4W)

    Arm title
    		 Dose Ranging Part: MBG453 240mg Q4W
    Arm description
    		 Sabatolimab 240 mg Q4W in Dose Ranging Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 240 mg every 4 weeks (Q4W)

    Arm title
    		 Dose Ranging Part: MBG453 1200mg Q4W
    Arm description
    		 Sabatolimab 1200 mg Q4W in Dose Ranging Part
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab
    Investigational medicinal product code
    MBG453
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 1200 mg every 4 weeks (Q4W)

    Arm title
    		 Phase II: MBG453 + PDR001 NSCLC
    Arm description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in non-small cell lung carcinoma (NSCLC)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W

    Arm title
    		 Phase II: MBG453 + PDR001 Melanoma
    Arm description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in melanoma
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sabatolimab+spartalizumab
    Investigational medicinal product code
    MBG453+PDR001
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W

    Number of subjects in period 1
    		Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Started
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    17
    16
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    17
    16
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    1
    1
    1
    -
    -
    2
    1
    1
         Adverse Event
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
    -
    -
    1
    1
    -
    -
    1
    -
    -
    -
    1
    -
         Death
    1
    -
    -
    -
    -
    -
    -
    -
    1
    1
    -
    -
    -
    -
    -
    1
    -
    1
    -
    1
    1
    -
    -
    -
    1
    2
    -
    1
    4
    -
         Progressive disease
    12
    8
    13
    5
    2
    4
    6
    2
    5
    6
    5
    5
    4
    11
    6
    3
    5
    5
    5
    2
    10
    4
    5
    5
    3
    11
    16
    11
    10
    15
         Subject/guardian decision
    1
    1
    2
    -
    -
    -
    -
    -
    2
    2
    -
    1
    -
    1
    -
    1
    -
    -
    1
    -
    -
    -
    1
    -
    -
    1
    1
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase I Dose Escalation: MBG453 80mg Q2W ROW
    Reporting group description
    		 Sabatolimab 80 mg every 2 weeks (Q2W) in Phase I Dose Escalation Part in rest of the world (ROW) patients

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q2W ROW
    Reporting group description
    		 Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q2W ROW
    Reporting group description
    		 Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q2W ROW
    Reporting group description
    		 Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 80mg Q2W Japan
    Reporting group description
    		 Sabatolimab 80 mg Q2W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q2W Japan
    Reporting group description
    		 Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q2W Japan
    Reporting group description
    		 Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q2W Japan
    Reporting group description
    		 Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in Japanese participants

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q4W ROW
    Reporting group description
    		 Sabatolimab 240 mg every 4 weeks (Q4W) in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q4W ROW
    Reporting group description
    		 Sabatolimab 800 mg Q4W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q4W ROW
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q4W Japan
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 20 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 80 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 240 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W
    Reporting group description
    		 Sabatolimab 240 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 800 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W
    Reporting group description
    		 Sabatolimab 800 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W
    Reporting group description
    		 Sabatolimab 80 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 80 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 240 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Dose Ranging Part: MBG453 80mg Q4W
    Reporting group description
    		 Sabatolimab 80 mg Q4W in Dose Ranging Part

    Reporting group title
    Dose Ranging Part: MBG453 240mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in Dose Ranging Part

    Reporting group title
    Dose Ranging Part: MBG453 1200mg Q4W
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in Dose Ranging Part

    Reporting group title
    Phase II: MBG453 + PDR001 NSCLC
    Reporting group description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in non-small cell lung carcinoma (NSCLC)

    Reporting group title
    Phase II: MBG453 + PDR001 Melanoma
    Reporting group description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in melanoma

    Reporting group values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma Total
    Number of subjects
    		 14 9 16 5 2 4 6 2 8 9 6 6 6 13 6 5 5 6 6 3 12 5 7 6 6 14 17 15 17 16 252
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 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 0 0 0 0 0
        Adolescents (12-17 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 0 0 0 0 0
        Adults (18-64 years)
    		 10 6 12 4 0 1 4 2 6 5 3 3 4 8 5 3 3 4 4 1 4 3 4 5 3 10 11 11 7 8 154
        From 65-84 years
    		 4 3 4 1 2 3 2 0 2 4 3 3 2 5 1 2 2 2 2 2 8 1 3 1 3 4 6 4 10 8 97
        85 years and over
    		 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 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.3 ( 13.80 ) 50.7 ( 16.69 ) 53.6 ( 15.95 ) 57.2 ( 8.07 ) 73.0 ( 8.49 ) 65.8 ( 5.74 ) 54.0 ( 16.64 ) 55.0 ( 7.07 ) 56.1 ( 12.76 ) 62.2 ( 10.86 ) 60.8 ( 13.09 ) 63.5 ( 7.40 ) 47.8 ( 13.92 ) 56.9 ( 13.98 ) 56.5 ( 16.56 ) 54.6 ( 15.87 ) 56.0 ( 10.58 ) 54.0 ( 12.77 ) 54.2 ( 14.47 ) 62.3 ( 22.37 ) 66.0 ( 7.02 ) 59.4 ( 20.16 ) 61.3 ( 14.51 ) 53.8 ( 10.36 ) 57.7 ( 12.16 ) 57.4 ( 12.20 ) 59.4 ( 10.12 ) 57.3 ( 11.85 ) 64.5 ( 10.28 ) 61.8 ( 11.35 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 8 5 5 3 1 2 4 1 6 4 3 3 2 7 2 2 0 4 3 2 5 2 3 4 3 10 14 13 3 8 132
        Male
    		 6 4 11 2 1 2 2 1 2 5 3 3 4 6 4 3 5 2 3 1 7 3 4 2 3 4 3 2 14 8 120
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 12 9 12 4 0 0 0 0 7 9 5 0 2 11 4 4 2 4 3 2 10 4 5 3 5 12 15 14 11 8 177
        Asian
    		 1 0 3 1 2 4 6 2 1 0 1 6 3 2 2 1 3 1 3 1 2 1 2 2 1 1 1 0 5 8 66
        Black
    		 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 1 0 1 0 0 4
        Unknown
    		 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 0 0 2
        Other
    		 1 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 1 0 3

    End points

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    End points reporting groups
    Reporting group title
    Phase I Dose Escalation: MBG453 80mg Q2W ROW
    Reporting group description
    		 Sabatolimab 80 mg every 2 weeks (Q2W) in Phase I Dose Escalation Part in rest of the world (ROW) patients

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q2W ROW
    Reporting group description
    		 Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q2W ROW
    Reporting group description
    		 Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q2W ROW
    Reporting group description
    		 Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 80mg Q2W Japan
    Reporting group description
    		 Sabatolimab 80 mg Q2W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q2W Japan
    Reporting group description
    		 Sabatolimab 240 mg Q2W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q2W Japan
    Reporting group description
    		 Sabatolimab 800 mg Q2W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q2W Japan
    Reporting group description
    		 Sabatolimab 1200 mg Q2W in Phase I Dose Escalation Part in Japanese participants

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q4W ROW
    Reporting group description
    		 Sabatolimab 240 mg every 4 weeks (Q4W) in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q4W ROW
    Reporting group description
    		 Sabatolimab 800 mg Q4W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q4W ROW
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in ROW patients

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q4W Japan
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in Phase I Dose Escalation Part in Japanese patients

    Reporting group title
    Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 20 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 80 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 240 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W
    Reporting group description
    		 Sabatolimab 240 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Sabatolimab 800 mg Q2W in combination with spartalizumab 80 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W
    Reporting group description
    		 Sabatolimab 800 mg Q2W in combination with spartalizumab 240 mg Q2W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W
    Reporting group description
    		 Sabatolimab 80 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 80 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 80 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 240 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in combination with spartalizumab 400 mg Q4W in Phase Ib Dose Escalation Part

    Reporting group title
    Dose Ranging Part: MBG453 80mg Q4W
    Reporting group description
    		 Sabatolimab 80 mg Q4W in Dose Ranging Part

    Reporting group title
    Dose Ranging Part: MBG453 240mg Q4W
    Reporting group description
    		 Sabatolimab 240 mg Q4W in Dose Ranging Part

    Reporting group title
    Dose Ranging Part: MBG453 1200mg Q4W
    Reporting group description
    		 Sabatolimab 1200 mg Q4W in Dose Ranging Part

    Reporting group title
    Phase II: MBG453 + PDR001 NSCLC
    Reporting group description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in non-small cell lung carcinoma (NSCLC)

    Reporting group title
    Phase II: MBG453 + PDR001 Melanoma
    Reporting group description
    		 Sabatolimab 800 mg Q4W in combination with spartalizumab 400 mg Q4W in melanoma

    Primary: Phase I-Ib and Dose Ranging Part: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) during the on-treatment period

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    End point title
    		 Phase I-Ib and Dose Ranging Part: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) during the on-treatment period [1] [2]
    End point description
    Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
    End point type
    Primary
    End point timeframe
    From first dose of study medication up to 30 days after last dose, with a maximum duration of 2 years for sabatolimab and 5 years for sabatolimab in combination with spartalizumab
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were 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: This endpoint only applies to Phase I-Ib and Dose Ranging Part
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    Units: participants
        AEs
    13
    9
    14
    5
    2
    3
    6
    2
    7
    9
    6
    5
    6
    12
    6
    5
    5
    6
    6
    3
    11
    5
    7
    6
    6
    13
    17
    14
        Treatment-related AEs
    9
    5
    6
    1
    0
    0
    1
    0
    4
    6
    2
    1
    5
    7
    5
    4
    2
    4
    3
    1
    5
    5
    3
    4
    2
    3
    7
    10
        AEs with grade ≥ 3
    5
    3
    6
    2
    0
    1
    2
    0
    3
    7
    4
    3
    4
    9
    3
    5
    3
    0
    4
    1
    3
    3
    6
    5
    4
    10
    7
    10
        Treatment-related AEs with grade ≥ 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    1
    0
    0
    1
    0
    2
    0
    1
    1
    0
    1
    1
    2
        SAEs
    4
    1
    6
    2
    0
    0
    0
    0
    1
    5
    4
    0
    2
    6
    2
    4
    4
    0
    4
    1
    2
    3
    1
    3
    3
    8
    7
    7
        Fatal SAEs
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        AEs leading to discontinuation
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    1
    1
    0
        AEs leading to dose adjustment/interruption
    3
    0
    3
    0
    0
    1
    1
    1
    1
    2
    0
    1
    3
    3
    3
    1
    3
    1
    1
    1
    1
    0
    1
    2
    2
    1
    0
    2
        AEs requiring additional therapy
    13
    4
    12
    4
    2
    3
    6
    2
    7
    7
    3
    3
    5
    12
    4
    5
    4
    4
    6
    3
    10
    5
    3
    6
    5
    12
    17
    12
    No statistical analyses for this end point

    Primary: Phase I-Ib: Number of participants with Dose-Limiting Toxicities (DLTs)

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    End point title
    		 Phase I-Ib: Number of participants with Dose-Limiting Toxicities (DLTs) [3] [4]
    End point description
    A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with sabatolimab as single agent or in the first two cycles of treatment when sabatolimab is given in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. The duration of one treatment cycle is 28 days.
    End point type
    Primary
    End point timeframe
    28 days (sabatolimab single agent) and 56 days (sabatolimab+spartalizumab)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were 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: This endpoint only applies to Phase I-Ib
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W
    Number of subjects analysed
    13
    9
    12
    5
    2
    4
    6
    2
    8
    8
    5
    6
    6
    12
    4
    4
    5
    5
    6
    2
    12
    5
    5
    4
    3
    Units: participants
    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
    No statistical analyses for this end point

    Primary: Phase I-Ib and Dose Ranging Part: Number of participants with dose reductions and dose interruptions of sabatolimab

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    End point title
    		 Phase I-Ib and Dose Ranging Part: Number of participants with dose reductions and dose interruptions of sabatolimab [5] [6]
    End point description
    Number of participants with at least one dose reduction of sabatolimab and number of participants with at least one dose interruption of sabatolimab.
    End point type
    Primary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were 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: This endpoint only applies to Phase I-Ib and Dose Ranging Part
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    Units: participants
        At least one dose reduction
    0
    0
    2
    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
        At least one dose interruption
    2
    1
    3
    0
    0
    2
    1
    0
    0
    1
    0
    0
    2
    2
    1
    1
    2
    1
    1
    0
    0
    0
    2
    1
    1
    1
    0
    1
    No statistical analyses for this end point

    Primary: Phase Ib: Number of participants with dose reductions and dose interruptions of spartalizumab

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    End point title
    		 Phase Ib: Number of participants with dose reductions and dose interruptions of spartalizumab [7] [8]
    End point description
    Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab.
    End point type
    Primary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 4.9 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: No statistical analysis were 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: This endpoint only applies to Phase Ib
    End point values
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W
    Number of subjects analysed
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    Units: participants
        At least one dose reduction
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        At least one dose interruption
    2
    2
    1
    1
    2
    1
    1
    0
    0
    0
    2
    1
    1
    No statistical analyses for this end point

    Primary: Phase I-Ib and Dose Ranging Part: Dose intensity of sabatolimab

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    End point title
    		 Phase I-Ib and Dose Ranging Part: Dose intensity of sabatolimab [9] [10]
    End point description
    Dose intensity of sabatolimab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of sabatolimab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
    End point type
    Primary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
    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: No statistical analysis were 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: This endpoint only applies to Phase I-Ib and Dose Ranging Part
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    Units: milligrams
        arithmetic mean (standard deviation)
    78.35 ( 4.678 )
    235.60 ( 17.140 )
    728.06 ( 164.525 )
    1203.03 ( 15.891 )
    80.00 ( 0.000 )
    217.50 ( 28.723 )
    758.03 ( 57.03 )
    1208.70 ( 12.298 )
    240.19 ( 1.954 )
    752.29 ( 123.021 )
    1193.10 ( 16.893 )
    1196.49 ( 8.595 )
    19.34 ( 1.043 )
    78.58 ( 2.872 )
    236.19 ( 15.050 )
    230.24 ( 19.982 )
    743.88 ( 79.534 )
    763.72 ( 89.571 )
    76.39 ( 5.315 )
    80.11 ( 0.184 )
    239.36 ( 4.227 )
    236.00 ( 7.800 )
    230.28 ( 21.179 )
    755.79 ( 103.897 )
    1196.15 ( 9.421 )
    79.55 ( 1.661 )
    239.68 ( 4.977 )
    1192.33 ( 23.366 )
    No statistical analyses for this end point

    Primary: Phase Ib: Dose intensity of spartalizumab

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    End point title
    		 Phase Ib: Dose intensity of spartalizumab [11] [12]
    End point description
    Dose intensity of spartalizumab Q2W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 14 days. Dose intensity of spartalizumab Q4W was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
    End point type
    Primary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 4.9 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: No statistical analysis were 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: This endpoint only applies to Phase Ib
    End point values
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W
    Number of subjects analysed
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    Units: milligrams
        arithmetic mean (standard deviation)
    77.36 ( 4.171 )
    77.83 ( 3.957 )
    78.73 ( 5.017 )
    230.24 ( 19.982 )
    74.39 ( 7.953 )
    229.12 ( 26.871 )
    76.39 ( 5.315 )
    400.53 ( 0.920 )
    79.79 ( 1.409 )
    236.00 ( 7.800 )
    383.22 ( 36.754 )
    377.89 ( 51.948 )
    398.72 ( 3.140 )
    No statistical analyses for this end point

    Primary: Phase II: Overall Response Rate (ORR) per RECIST v1.1

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    End point title
    		 Phase II: Overall Response Rate (ORR) per RECIST v1.1 [13] [14]
    End point description
    Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
    End point type
    Primary
    End point timeframe
    From start of treatment until end of treatment, assessed up to 2.9 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: No statistical analysis were 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: This endpoint only applies to Phase II
    End point values
    		 Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    17
    16
    Units: Percentage of participants
        number (confidence interval 90%)
    0 (0.0 to 16.2)
    0 (0.0 to 17.1)
    No statistical analyses for this end point

    Secondary: Best Overall Response (BOR) per RECIST v1.1

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    End point title
    		 Best Overall Response (BOR) per RECIST v1.1
    End point description
    BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression; NCRNPD: Persistence of one or more non-target lesions. Number of participants in each category is reported in the table.
    End point type
    Secondary
    End point timeframe
    From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    17
    16
    Units: participants
        Complete Response (CR)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Partial Response (PR)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
        Stable Disease (SD)
    4
    3
    7
    0
    0
    1
    2
    0
    3
    1
    0
    3
    4
    7
    2
    1
    1
    1
    3
    1
    5
    3
    2
    2
    1
    4
    2
    4
    6
    3
        Progressive Disease (PD)
    7
    6
    8
    5
    2
    3
    4
    2
    3
    4
    4
    3
    1
    4
    4
    4
    3
    4
    3
    1
    7
    2
    1
    3
    3
    7
    13
    8
    5
    12
        Non-CR/Non-PD (NCRNPD)
    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
        Unknown
    3
    0
    1
    0
    0
    0
    0
    0
    1
    4
    2
    0
    0
    1
    0
    0
    1
    1
    0
    1
    0
    0
    2
    0
    2
    3
    2
    3
    6
    1
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) per RECIST v1.1

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    End point title
    		 Progression-Free Survival (PFS) per RECIST v1.1
    End point description
    PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1. PFS was analyzed using Kaplan-Meier estimates. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not available’). Therefore, not available values because of insufficient number of participants with events are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    From start of treatment until first documented progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    17
    16
    Units: months
        median (confidence interval 90%)
    1.8 (1.7 to 3.3)
    1.8 (1.6 to 2.8)
    1.8 (1.7 to 5.3)
    1.7 (1.3 to 999)
    1.5 (1.4 to 999)
    1.9 (1.0 to 999)
    2.0 (1.0 to 3.3)
    1.6 (1.4 to 999)
    1.7 (1.0 to 999)
    1.7 (0.7 to 1.8)
    1.8 (1.6 to 999)
    2.0 (1.1 to 3.5)
    3.6 (1.8 to 999)
    3.6 (1.8 to 3.7)
    1.7 (1.0 to 3.7)
    1.8 (1.0 to 999)
    1.8 (1.7 to 999)
    1.7 (0.5 to 1.8)
    2.6 (1.6 to 3.7)
    2.4 (1.8 to 999)
    1.8 (1.7 to 3.0)
    3.5 (1.8 to 999)
    999 (1.5 to 999)
    2.7 (1.1 to 3.8)
    1.7 (0.2 to 2.4)
    1.8 (1.7 to 3.7)
    1.7 (1.6 to 1.8)
    1.7 (1.7 to 2.1)
    1.7 (1.1 to 3.4)
    1.8 (1.7 to 1.9)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) per RECIST v1.1

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    End point title
    		 Duration of Response (DOR) per RECIST v1.1
    End point description
    DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment according to RECIST v1.1. DOR is defined as the time from the date of first documented response to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, duration was censored at the date of last adequate tumor assessment. According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA). Therefore, not available values because of insufficient number of responders as per SAP are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    From first documented response to first documented disease progression or death due to underlying cancer, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    1
    1
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    2
    1
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    Units: months
        median (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    999 (999 to 999)
    999 (999 to 999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    999 (999 to 999)
    999 (999 to 999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [15] - No patients with CR or PR
    [16] - No patients with CR or PR
    [17] - No patients with CR or PR
    [18] - No patients with CR or PR
    [19] - No patients with CR or PR
    [20] - No patients with CR or PR
    [21] - No patients with CR or PR
    [22] - No patients with CR or PR
    [23] - No patients with CR or PR
    [24] - No patients with CR or PR
    [25] - No patients with CR or PR
    [26] - No patients with CR or PR
    [27] - No patients with CR or PR
    [28] - No patients with CR or PR
    [29] - No patients with CR or PR
    [30] - No patients with CR or PR
    [31] - No patients with CR or PR
    [32] - No patients with CR or PR
    [33] - No patients with CR or PR
    [34] - No patients with CR or PR
    [35] - No patients with CR or PR
    [36] - No patients with CR or PR
    [37] - No patients with CR or PR
    [38] - No patients with CR or PR
    [39] - No patients with CR or PR
    [40] - No patients with CR or PR
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) per irRC

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    End point title
    		 Overall Response Rate (ORR) per irRC
    End point description
    Tumor response was based on local investigator assessment as per irRC. ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters.
    End point type
    Secondary
    End point timeframe
    From start of treatment until end of treatment, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    17
    16
    Units: Percentage of participants
        number (confidence interval 90%)
    0 (0.0 to 19.3)
    0 (0.0 to 28.3)
    0 (0.0 to 17.1)
    0 (0.0 to 45.1)
    0 (0.0 to 77.6)
    0 (0.0 to 52.7)
    0 (0.0 to 39.3)
    0 (0.0 to 77.6)
    0 (0.0 to 31.2)
    0 (0.0 to 28.3)
    0 (0.0 to 39.3)
    0 (0.0 to 39.3)
    16.7 (0.9 to 58.2)
    7.7 (0.4 to 31.6)
    0 (0.0 to 39.3)
    0 (0.0 to 45.1)
    0 (0.0 to 45.1)
    0 (0.0 to 39.3)
    0 (0.0 to 39.3)
    0 (0.0 to 63.2)
    0 (0.0 to 22.1)
    0 (0.0 to 45.1)
    28.6 (5.3 to 65.9)
    16.7 (0.9 to 58.2)
    0 (0.0 to 39.3)
    0 (0.0 to 19.3)
    0 (0.0 to 16.2)
    0 (0.0 to 18.1)
    0 (0.0 to 16.2)
    0 (0.0 to 17.1)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) per irRC

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    End point title
    		 Progression-Free Survival (PFS) per irRC
    End point description
    PFS is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor evaluation. Tumor response was based on local investigator assessment per irRC. PFS was analyzed using Kaplan-Meier estimates. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not available’). Therefore, not available values because of insufficient number of participants with events are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    From start of treatment until first documented and confirmed progression or death due to any cause, assessed up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    17
    16
    Units: months
        median (confidence interval 90%)
    1.8 (1.7 to 3.3)
    1.8 (1.6 to 3.0)
    1.8 (1.7 to 5.3)
    1.7 (1.3 to 999)
    1.5 (1.4 to 999)
    1.9 (1.0 to 999)
    2.0 (1.0 to 3.3)
    1.6 (1.4 to 999)
    1.7 (1.0 to 999)
    1.8 (0.7 to 2.5)
    2.3 (1.8 to 999)
    2.0 (1.1 to 3.5)
    3.6 (1.8 to 999)
    3.6 (1.8 to 3.7)
    1.7 (1.0 to 3.7)
    1.8 (1.0 to 999)
    1.8 (1.7 to 999)
    1.7 (0.5 to 1.8)
    2.6 (1.6 to 3.7)
    2.4 (1.8 to 999)
    2.3 (1.7 to 3.6)
    5.5 (3.5 to 999)
    999 (1.5 to 999)
    2.7 (1.1 to 3.8)
    1.7 (0.2 to 2.4)
    1.8 (1.7 to 3.2)
    1.7 (1.6 to 1.8)
    1.7 (1.7 to 2.1)
    1.7 (1.1 to 3.4)
    1.8 (1.7 to 1.9)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. OS was estimated using Kaplan-Meier estimates. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not available’). Therefore, not available values because of insufficient number of participants with events are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    From start of treatment until death due to any cause, assessed up to 2 years for sabatolimab and 5.3 years for sabatolimab in combination with spartalizumab
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14
    9
    16
    5
    2
    4
    6
    2
    8
    9
    6
    6
    6
    13
    6
    5
    5
    6
    6
    3
    12
    5
    7
    6
    6
    14
    17
    15
    17
    16
    Units: months
        median (confidence interval 90%)
    4.1 (2.4 to 7.7)
    6.7 (4.6 to 9.2)
    10.3 (4.9 to 15.9)
    4.3 (1.4 to 999)
    4.1 (1.8 to 999)
    4.2 (2.3 to 999)
    5.0 (1.7 to 7.5)
    8.5 (3.1 to 999)
    12.5 (1.8 to 999)
    2.5 (1.6 to 11.1)
    4.8 (2.8 to 999)
    6.6 (1.9 to 11.5)
    24.4 (3.4 to 999)
    10.0 (6.2 to 41.8)
    9.6 (1.5 to 999)
    3.1 (1.2 to 999)
    20.6 (2.0 to 999)
    5.4 (0.5 to 999)
    999 (8.1 to 999)
    3.6 (2.4 to 999)
    8.6 (4.9 to 18.3)
    12.3 (3.7 to 999)
    24.8 (1.5 to 999)
    18.0 (1.4 to 999)
    2.4 (0.2 to 6.8)
    4.0 (1.8 to 13.8)
    4.9 (3.4 to 11.2)
    10.9 (2.2 to 14.6)
    6.6 (1.1 to 9.0)
    6.7 (5.2 to 13.3)
    No statistical analyses for this end point

    Secondary: Maximum observed serum concentration (Cmax) of sabatolimab

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    End point title
    		 Maximum observed serum concentration (Cmax) of sabatolimab
    End point description
    Pharmacokinetic (PK) parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14 [41]
    9 [42]
    16 [43]
    5 [44]
    2 [45]
    4 [46]
    6 [47]
    2 [48]
    8 [49]
    9 [50]
    6 [51]
    6 [52]
    6 [53]
    13 [54]
    6 [55]
    4 [56]
    4 [57]
    6 [58]
    6 [59]
    3 [60]
    12 [61]
    5 [62]
    6 [63]
    6 [64]
    5 [65]
    14 [66]
    17 [67]
    15 [68]
    17 [69]
    16 [70]
    Units: µg/mL
    arithmetic mean (standard deviation)
        Cycle 1
    23 ( 6.28 )
    81.3 ( 24.4 )
    251 ( 57.3 )
    429 ( 152 )
    36.1 ( 0.919 )
    74 ( 8.59 )
    321 ( 64.2 )
    443 ( 4.24 )
    98.8 ( 50.8 )
    271 ( 78.5 )
    304 ( 86.5 )
    457 ( 135 )
    7.68 ( 3.68 )
    23 ( 6.38 )
    83 ( 20.7 )
    58.3 ( 12.7 )
    213 ( 4.19 )
    189 ( 70.6 )
    22.9 ( 5.91 )
    23.3 ( 0.529 )
    72 ( 18.3 )
    59.7 ( 30.2 )
    79 ( 26 )
    254 ( 38.7 )
    343 ( 112 )
    34.6 ( 21.8 )
    86.2 ( 27 )
    394 ( 86.7 )
    185 ( 64.6 )
    233 ( 60.3 )
        Cycle 3
    24.8 ( 13.5 )
    144 ( 60.8 )
    420 ( 138 )
    563 ( 999 )
    999 ( 999 )
    999 ( 999 )
    443 ( 190 )
    709 ( 999 )
    116 ( 28.6 )
    333 ( 39.6 )
    448 ( 999 )
    713 ( 14.8 )
    12.7 ( 16.8 )
    40.2 ( 31.1 )
    101 ( 25.6 )
    45.4 ( 999 )
    379 ( 104 )
    422 ( 49.5 )
    25.8 ( 5.22 )
    18.6 ( 0.99 )
    77 ( 27.2 )
    104 ( 32.5 )
    102 ( 32.5 )
    286 ( 60.8 )
    557 ( 999 )
    31.2 ( 5.58 )
    94.4 ( 19.1 )
    412 ( 124 )
    267 ( 82.5 )
    316 ( 105 )
    Notes
    [41] - n=14 (Cycle 1), 8 (Cycle 3)
    [42] - n=9 (Cycle 1), 5 (Cycle 3)
    [43] - n=16 (Cycle 1), 10 (Cycle 3)
    [44] - n=5 (Cycle 1), 1 (Cycle 3)
    [45] - n=2 (Cycle 1), 0 (Cycle 3)
    [46] - n=4 (Cycle 1), 0 (Cycle 3)
    [47] - n=6 (Cycle 1), 3 (Cycle 3)
    [48] - n=2 (Cycle 1), 1 (Cycle 3)
    [49] - n=8 (Cycle 1), 2 (Cycle 3)
    [50] - n= 9 (Cycle 1), 2 (Cycle 3)
    [51] - n=6 (Cycle 1), 1 (Cycle 3)
    [52] - n=6 (Cycle 1), 2 (Cycle 3)
    [53] - n=6 (Cycle 1), 6 (Cycle 3)
    [54] - n=13 (Cycle 1), 8 (Cycle 3)
    [55] - n=6 (Cycle 1), 3 (Cycle 3)
    [56] - n=4 (Cycle 1), 1 (Cycle 3)
    [57] - n=4 (Cycle 1), 3 (Cycle 3)
    [58] - n=6 (Cycle 1), 2 (Cycle 3)
    [59] - n=6 (Cycle 1), 4 (Cycle 3)
    [60] - n=3 (Cycle 1), 2 (Cycle 3)
    [61] - n=12 (Cycle 1), 8 (Cycle 3)
    [62] - n=5 (Cycle 1), 4 (Cycle 3)
    [63] - n=6 (Cycle 1), 5 (Cycle 3)
    [64] - n=6 (Cycle 1), 4 (Cycle 3)
    [65] - n=5 (Cycle 1), 1 (Cycle 3)
    [66] - n=14 (Cycle 1), 6 (Cycle 3)
    [67] - n=17 (Cycle 1), 5 (Cycle 3)
    [68] - n=15 (Cycle 1), 4 (Cycle 3)
    [69] - n=17 (Cycle 1), 8 (Cycle 3)
    [70] - n=16 (Cycle 1), 9 (Cycle 3)
    No statistical analyses for this end point

    Secondary: Time to reach maximum serum concentration (Tmax) of sabatolimab

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    End point title
    		 Time to reach maximum serum concentration (Tmax) of sabatolimab
    End point description
    PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14 [71]
    9 [72]
    16 [73]
    5 [74]
    2 [75]
    4 [76]
    6 [77]
    2 [78]
    8 [79]
    9 [80]
    6 [81]
    6 [82]
    6 [83]
    13 [84]
    6 [85]
    4 [86]
    4 [87]
    6 [88]
    6 [89]
    3 [90]
    12 [91]
    5 [92]
    6 [93]
    6 [94]
    4 [95]
    14 [96]
    17 [97]
    15 [98]
    15 [99]
    16 [100]
    Units: hours
    median (full range (min-max))
        Cycle 1
    1.53 (1.5 to 2.08)
    1.5 (0.667 to 24.4)
    1.57 (1.42 to 1.88)
    1.53 (1.5 to 22.6)
    1.57 (1.53 to 1.6)
    1.57 (1.55 to 1.67)
    1.56 (1.5 to 1.62)
    1.53 (1.52 to 1.55)
    1.58 (1.5 to 2)
    1.5 (1.42 to 2.17)
    1.53 (1.48 to 23.2)
    1.55 (1.52 to 1.6)
    4 (4 to 4)
    3.08 (2.72 to 4.08)
    3.13 (1.53 to 4.08)
    3.09 (1.17 to 3.33)
    3.08 (1.6 to 3.47)
    3.48 (3.08 to 162)
    3.32 (3.08 to 3.55)
    3 (1.68 to 3.38)
    3.17 (2.52 to 4.12)
    3.25 (1.55 to 359)
    3.21 (3.07 to 21.9)
    3.08 (3 to 4)
    3.23 (3.05 to 26.3)
    1.5 (1.5 to 24.5)
    1.58 (1.5 to 140)
    1.67 (1.33 to 24.3)
    3.37 (3 to 164)
    3.15 (3 to 26)
        Cycle 3
    1.54 (1.5 to 1.67)
    1.58 (0.583 to 24.5)
    1.53 (0.483 to 1.93)
    1.7 (1.7 to 1.7)
    999 (999 to 999)
    999 (999 to 999)
    1.55 (1.48 to 1.58)
    1.62 (1.62 to 1.62)
    1.21 (0.833 to 1.58)
    1.63 (1.58 to 1.67)
    1.5 (1.5 to 1.5)
    1.57 (1.55 to 1.58)
    3.25 (3.25 to 3.25)
    3.31 (3 to 164)
    3 (1.62 to 3.08)
    999 (999 to 999)
    3.2 (3.03 to 3.3)
    3.04 (3 to 3.08)
    3.38 (3 to 19.7)
    3 (3 to 3)
    3.13 (2.9 to 24)
    3.04 (0 to 3.57)
    3.08 (3.08 to 3.23)
    3 (3 to 3.07)
    3.5 (3.5 to 3.5)
    1.58 (1.5 to 1.65)
    1.58 (1.5 to 1.7)
    1.58 (1.57 to 23.8)
    3.08 (1.43 to 25)
    3.24 (3.08 to 3.4)
    Notes
    [71] - n=14 (Cycle 1), 8 (Cycle 3)
    [72] - n=9 (Cycle 1), 5 (Cycle 3)
    [73] - n=16 (Cycle 1), 10 (Cycle 3)
    [74] - n=5 (Cycle 1), 1 (Cycle 3)
    [75] - n=2 (Cycle 1), 0 (Cycle 3)
    [76] - n=4 (Cycle 1), 0 (Cycle 3)
    [77] - n=6 (Cycle 1), 3 (Cycle 3)
    [78] - n=2 (Cycle 1), 1 (Cycle 3)
    [79] - n=8 (Cycle 1), 2 (Cycle 3)
    [80] - n=9 (Cycle 1), 2 (Cycle 3)
    [81] - n=6 (Cycle 1), 1 (Cycle 3)
    [82] - n=6 (Cycle 1), 2 (Cycle 3)
    [83] - n=6 (Cycle 1), 1 (Cycle 3)
    [84] - n=13 (Cycle 1), 8 (Cycle 3)
    [85] - n=6 (Cycle 1), 3 (Cycle 3)
    [86] - n=4 (Cycle 1), 0 (Cycle 3)
    [87] - n=4 (Cycle 1), 3 (Cycle 3)
    [88] - n=6 (Cycle 1), 2 (Cycle 3)
    [89] - n=6 (Cycle 1), 3 (Cycle 3)
    [90] - n=3 (Cycle 1), 1 (Cycle 3)
    [91] - n=12 (Cycle 1), 8 (Cycle 3)
    [92] - n=5 (Cycle 1), 4 (Cycle 3)
    [93] - n=6 (Cycle 1), 5 (Cycle 3)
    [94] - n=6 (Cycle 1), 4 (Cycle 3)
    [95] - n=4 (Cycle 1), 1 (Cycle 3)
    [96] - n=14 (Cycle 1), 6 (Cycle 3)
    [97] - n=17 (Cycle 1), 5 (Cycle 3)
    [98] - n=15 (Cycle 1), 4 (Cycle 3)
    [99] - n=15 (Cycle 1), 8 (Cycle 3)
    [100] - n=16 (Cycle 1), 6 (Cycle 3)
    No statistical analyses for this end point

    Secondary: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of sabatolimab

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    End point title
    		 Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of sabatolimab
    End point description
    PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14 [101]
    9 [102]
    16 [103]
    5 [104]
    2 [105]
    4 [106]
    6 [107]
    2 [108]
    7 [109]
    8 [110]
    6 [111]
    6 [112]
    1 [113]
    12 [114]
    6 [115]
    4 [116]
    4 [117]
    5 [118]
    6 [119]
    3 [120]
    12 [121]
    5 [122]
    6 [123]
    6 [124]
    4 [125]
    12 [126]
    17 [127]
    15 [128]
    15 [129]
    16 [130]
    Units: day*µg/mL
    arithmetic mean (standard deviation)
        Cycle 1
    128 ( 33.2 )
    555 ( 191 )
    1670 ( 438 )
    2780 ( 862 )
    231 ( 4.77 )
    463 ( 47.9 )
    2070 ( 570 )
    3220 ( 107 )
    851 ( 425 )
    2290 ( 793 )
    2800 ( 921 )
    4480 ( 1610 )
    86.5 ( 999 )
    126 ( 34.7 )
    502 ( 146 )
    393 ( 197 )
    1550 ( 115 )
    1450 ( 546 )
    149 ( 63.1 )
    109 ( 57.5 )
    673 ( 245 )
    606 ( 302 )
    702 ( 329 )
    1870 ( 570 )
    3450 ( 2020 )
    216 ( 85.3 )
    805 ( 278 )
    3710 ( 1280 )
    1820 ( 735 )
    2430 ( 988 )
        Cycle 3
    172 ( 157 )
    1350 ( 576 )
    3270 ( 900 )
    4980 ( 999 )
    999 ( 999 )
    999 ( 999 )
    2300 ( 407 )
    999 ( 999 )
    1100 ( 559 )
    3590 ( 1120 )
    2800 ( 999 )
    9080 ( 648 )
    321 ( 999 )
    357 ( 356 )
    824 ( 149 )
    999 ( 999 )
    3110 ( 721 )
    4040 ( 894 )
    165 ( 57.3 )
    124 ( 999 )
    710 ( 337 )
    1310 ( 603 )
    989 ( 425 )
    2690 ( 1060 )
    3530 ( 999 )
    223 ( 75.5 )
    892 ( 499 )
    3730 ( 1640 )
    3060 ( 1230 )
    4390 ( 1610 )
    Notes
    [101] - n=14 (Cycle 1), 7 (Cycle 3)
    [102] - n=9 (Cycle 1), 5 (Cycle 3)
    [103] - n=16 (Cycle 1), 10 (Cycle 3)
    [104] - n=5 (Cycle 1), 1 (Cycle 3)
    [105] - n=2 (Cycle 1), 0 (Cycle 3)
    [106] - n=4 (Cycle 1), 0 (Cycle 3)
    [107] - n=6 (Cycle 1), 2 (Cycle 3)
    [108] - n=2 (Cycle 1), 0 (Cycle 3)
    [109] - n=7 (Cycle 1), 2 (Cycle 3)
    [110] - n=8 (Cycle 1), 2 (Cycle 3)
    [111] - n=6 (Cycle 1), 1 (Cycle 3)
    [112] - n=6 (Cycle 1), 2 (Cycle 3)
    [113] - n=1 (Cycle 1), 1 (Cycle 3)
    [114] - n=12 (Cycle 1), 8 (Cycle 3)
    [115] - n=6 (Cycle 1), 3 (Cycle 3)
    [116] - n=4 (Cycle 1), 0 (Cycle 3)
    [117] - n=4 (Cycle 1), 3 (Cycle 3)
    [118] - n=5 (Cycle 1), 2 (Cycle 3)
    [119] - n=6 (Cycle 1), 3 (Cycle 3)
    [120] - n=3 (Cycle 1), 1 (Cycle 3)
    [121] - n=12 (Cycle 1), 8 (Cycle 3)
    [122] - n=5 (Cycle 1), 4 (Cycle 3)
    [123] - n=6 (Cycle 1), 5 (Cycle 3)
    [124] - n=6 (Cycle 1), 4 (Cycle 3)
    [125] - n=4 (Cycle 1), 1 (Cycle 3)
    [126] - n=12 (Cycle 1), 6 (Cycle 3)
    [127] - n=17 (Cycle 1), 5 (Cycle 3)
    [128] - n=15 (Cycle 1), 4 (Cycle 3)
    [129] - n=15 (Cycle 1), 8 (Cycle 3)
    [130] - n=16 (Cycle 1), 6 (Cycle 3)
    No statistical analyses for this end point

    Secondary: Terminal elimination half-life (T1/2) of sabatolimab

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    End point title
    		 Terminal elimination half-life (T1/2) of sabatolimab
    End point description
    PK parameters were calculated based on sabatolimab serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the sabatolimab infusion on Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    5
    3
    9
    1
    0 [131]
    0 [132]
    2
    0 [133]
    2
    2
    1
    2
    1
    7
    2
    0 [134]
    3
    2
    3
    1
    8
    4
    5
    4
    1
    5
    5
    3
    7
    6
    Units: days
        arithmetic mean (standard deviation)
    8.6 ( 4.9 )
    16.5 ( 6.61 )
    13.5 ( 5.1 )
    33.8 ( 999 )
    ( )
    ( )
    12.1 ( 2.35 )
    ( )
    23.3 ( 11.1 )
    13.7 ( 1.8 )
    6.38 ( 999 )
    14.3 ( 13 )
    17.5 ( 999 )
    13.7 ( 11.6 )
    16.5 ( 7.69 )
    ( )
    17.6 ( 0.142 )
    14.9 ( 6.72 )
    6.46 ( 1.55 )
    6.8 ( 999 )
    11.2 ( 5.27 )
    16.4 ( 7.48 )
    11.6 ( 3.66 )
    13.9 ( 1.48 )
    11.5 ( 999 )
    5.85 ( 1.77 )
    12 ( 4.33 )
    12.9 ( 5.62 )
    19.1 ( 8.69 )
    21.7 ( 2.14 )
    Notes
    [131] - No values available (n=0)
    [132] - No values available (n=0)
    [133] - No values available (n=0)
    [134] - No values available (n=0)
    No statistical analyses for this end point

    Secondary: Maximum observed serum concentration (Cmax) of spartalizumab

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    End point title
    		 Maximum observed serum concentration (Cmax) of spartalizumab [135]
    End point description
    PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    Notes
    [135] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to MBG453+PDR001 arms
    End point values
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    6 [136]
    13 [137]
    6 [138]
    4 [139]
    5 [140]
    6 [141]
    6 [142]
    3 [143]
    12 [144]
    5 [145]
    7 [146]
    6 [147]
    6 [148]
    17 [149]
    16 [150]
    Units: µg/mL
    arithmetic mean (standard deviation)
        Cycle 1
    21.3 ( 14.9 )
    24.8 ( 7.8 )
    20.1 ( 5.36 )
    66.2 ( 12.2 )
    18.6 ( 4.5 )
    71.9 ( 23.8 )
    28.8 ( 18.6 )
    78.1 ( 35.2 )
    24.3 ( 20.6 )
    65.1 ( 23.1 )
    121 ( 30 )
    113 ( 27 )
    112 ( 35.8 )
    98.1 ( 29.1 )
    126 ( 42.1 )
        Cycle 3
    38.4 ( 12 )
    40.6 ( 7.09 )
    34.5 ( 6.59 )
    50 ( 999 )
    40.2 ( 6.12 )
    125 ( 5.66 )
    27 ( 3.77 )
    122 ( 7.07 )
    24 ( 12.5 )
    97 ( 27.7 )
    152 ( 40.2 )
    134 ( 38.2 )
    80.5 ( 999 )
    143 ( 46.5 )
    174 ( 63.5 )
    Notes
    [136] - n=6 (Cycle 1), 6 (Cycle 3)
    [137] - n=13 (Cycle 1), 8 (Cycle 3)
    [138] - n=6 (Cycle 1), 3 (Cycle 3)
    [139] - n=4 (Cycle 1), 1 (Cycle 3)
    [140] - n=5 (Cycle 1), 3 (Cycle 3)
    [141] - n=6 (Cycle 1), 2 (Cycle 3)
    [142] - n=6 (Cycle 1), 4 (Cycle 3)
    [143] - n=3 (Cycle 1), 2 (Cycle 3)
    [144] - n=12 (Cycle 1), 8 (Cycle 3)
    [145] - n=5 (Cycle 1), 4 (Cycle 3)
    [146] - n=7 (Cycle 1), 5 (Cycle 3)
    [147] - n=6 (Cycle 1), 4 (Cycle 3)
    [148] - n=6 (Cycle 1), 1 (Cycle 3)
    [149] - n=17 (Cycle 1), 8 (Cycle 3)
    [150] - n=16 (Cycle 1), 9 (Cycle 3)
    No statistical analyses for this end point

    Secondary: Time to reach maximum serum concentration (Tmax) of spartalizumab

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    End point title
    		 Time to reach maximum serum concentration (Tmax) of spartalizumab [151]
    End point description
    PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    Notes
    [151] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to MBG453+PDR001 arms
    End point values
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    6 [152]
    12 [153]
    6 [154]
    4 [155]
    5 [156]
    5 [157]
    6 [158]
    3 [159]
    12 [160]
    5 [161]
    7 [162]
    6 [163]
    5 [164]
    15 [165]
    16 [166]
    Units: hours
    median (full range (min-max))
        Cycle 1
    1.67 (1.52 to 23.3)
    1.58 (1.33 to 23.6)
    1.83 (1.5 to 23)
    1.63 (1.52 to 2.08)
    1.57 (1.5 to 23.3)
    1.67 (1.57 to 1.92)
    1.61 (1.52 to 1.75)
    1.58 (1.5 to 23.2)
    1.63 (1.1 to 22.2)
    1.53 (1.45 to 21.9)
    1.65 (1.57 to 22.6)
    1.5 (1.43 to 2)
    1.58 (1.55 to 1.68)
    1.58 (1.5 to 3)
    1.58 (1.37 to 2)
        Cycle 3
    1.78 (1.53 to 21.2)
    1.5 (1.5 to 335)
    1.58 (1.5 to 21.2)
    999 (999 to 999)
    1.58 (1.53 to 1.6)
    13 (1.5 to 24.6)
    1.72 (1.18 to 21.2)
    1.5 (1.5 to 1.5)
    1.5 (1.42 to 1.8)
    1.52 (1.5 to 1.58)
    1.58 (1.57 to 1.58)
    1.5 (1.5 to 1.57)
    165 (165 to 165)
    1.58 (1.5 to 24.5)
    1.56 (1.52 to 1.62)
    Notes
    [152] - n=6 (Cycle 1), 5 (Cycle 3)
    [153] - n=12 (Cycle 1), 8 (Cycle 3)
    [154] - n=6 (Cycle 1), 3 (Cycle 3)
    [155] - n=4 (Cycle 1), 0 (Cycle 3)
    [156] - n=5 (Cycle 1), 3 (Cycle 3)
    [157] - n=5 (Cycle 1), 2 (Cycle 3)
    [158] - n=6 (Cycle 1), 3 (Cycle 3)
    [159] - n=3 (Cycle 1), 1 (Cycle 3)
    [160] - n=12 (Cycle 1), 8 (Cycle 3)
    [161] - n=5 (Cycle 1), 4 (Cycle 3)
    [162] - n=7 (Cycle 1), 5 (Cycle 3)
    [163] - n=6 (Cycle 1), 4 (Cycle 3)
    [164] - n=5 (Cycle 1), 1 (Cycle 3)
    [165] - n=15 (Cycle 1), 8 (Cycle 3)
    [166] - n=16 (Cycle 1), 6 (Cycle 3)
    No statistical analyses for this end point

    Secondary: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of spartalizumab

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    End point title
    		 Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of spartalizumab [167]
    End point description
    PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    Notes
    [167] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to MBG453+PDR001 arms
    End point values
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    5 [168]
    12 [169]
    6 [170]
    4 [171]
    5 [172]
    5 [173]
    6 [174]
    3 [175]
    12 [176]
    5 [177]
    7 [178]
    6 [179]
    5 [180]
    15 [181]
    16 [182]
    Units: day*µg/mL
    arithmetic mean (standard deviation)
        Cycle 1
    197 ( 61.5 )
    166 ( 44.3 )
    160 ( 45.5 )
    470 ( 173 )
    152 ( 45.3 )
    502 ( 157 )
    279 ( 89.5 )
    888 ( 452 )
    291 ( 313 )
    773 ( 289 )
    1300 ( 735 )
    1120 ( 366 )
    1180 ( 501 )
    1070 ( 322 )
    1570 ( 747 )
        Cycle 3
    366 ( 147 )
    389 ( 123 )
    314 ( 43 )
    999 ( 999 )
    348 ( 74.2 )
    1280 ( 213 )
    355 ( 58.4 )
    1800 ( 999 )
    266 ( 154 )
    1540 ( 558 )
    2080 ( 837 )
    1680 ( 610 )
    1620 ( 999 )
    1870 ( 775 )
    2890 ( 741 )
    Notes
    [168] - n=4 (Cycle 1), 5 (Cycle 3)
    [169] - n=12 (Cycle 1), 8 (Cycle 3)
    [170] - n=6 (Cycle 1), 3 (Cycle 3)
    [171] - n=4 (Cycle 1), 0 (Cycle 3)
    [172] - n=5 (Cycle 1), 3 (Cycle 3)
    [173] - n=5 (Cycle 1), 2 (Cycle 3)
    [174] - n=6 (Cycle 1), 3 (Cycle 3)
    [175] - n=3 (Cycle 1), 1 (Cycle 3)
    [176] - n=12 (Cycle 1), 8 (Cycle 3)
    [177] - n=5 (Cycle 1), 4 (Cycle 3)
    [178] - n=7 (Cycle 1), 5 (Cycle 3)
    [179] - n=6 (Cycle 1), 4 (Cycle 3)
    [180] - n=5 (Cycle 1), 1 (Cycle 3)
    [181] - n=15 (Cycle 1), 8 (Cycle 3)
    [182] - n=16 (Cycle 1), 6 (Cycle 3)
    No statistical analyses for this end point

    Secondary: Terminal elimination half-life (T1/2) of spartalizumab

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    End point title
    		 Terminal elimination half-life (T1/2) of spartalizumab [183]
    End point description
    PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-infusion and 1, 24, 168, 240 and 336 hours after completion of the spartalizumab infusion on Cycle 3 Day 1. The duration of the infusion was 30 minutes. The duration of one cycle was 28 days.
    Notes
    [183] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to MBG453+PDR001 arms
    End point values
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    4
    7
    2
    0 [184]
    2
    2
    3
    1
    8
    3
    5
    4
    1
    7
    5
    Units: days
        arithmetic mean (standard deviation)
    13.7 ( 6.46 )
    19.9 ( 13.9 )
    29.5 ( 19.4 )
    ( )
    13.2 ( 1.14 )
    17.4 ( 9.53 )
    30.6 ( 23.5 )
    32.1 ( 999 )
    15.7 ( 5.6 )
    23.6 ( 8.82 )
    24.3 ( 9.72 )
    22.9 ( 6.19 )
    28.7 ( 999 )
    24.5 ( 11.8 )
    22.7 ( 3.15 )
    Notes
    [184] - No values available (n=0)
    No statistical analyses for this end point

    Secondary: Number of participants with anti-sabatolimab antibodies

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    End point title
    		 Number of participants with anti-sabatolimab antibodies
    End point description
    Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-sabatolimab antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: • ADA-negative at baseline: ADA-negative sample at baseline • ADA-positive at baseline: ADA-positive sample at baseline • ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples • ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative • Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample • Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
    End point type
    Secondary
    End point timeframe
    Baseline (before first dose) and post-baseline (assessed throughout the treatment up to 1.9 years for sabatolimab and 4.9 years for sabatolimab in combination with spartalizumab)
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    8 [185]
    8 [186]
    14 [187]
    5 [188]
    2 [189]
    4 [190]
    6 [191]
    2 [192]
    5 [193]
    7 [194]
    5 [195]
    6 [196]
    6 [197]
    13 [198]
    5 [199]
    5 [200]
    4 [201]
    5 [202]
    6 [203]
    2 [204]
    12 [205]
    5 [206]
    5 [207]
    6 [208]
    2 [209]
    11 [210]
    13 [211]
    12 [212]
    13 [213]
    14 [214]
    Units: participants
        ADA-negative at baseline
    5
    8
    14
    5
    2
    4
    6
    2
    5
    7
    5
    6
    6
    12
    4
    5
    4
    4
    5
    2
    12
    5
    4
    5
    1
    9
    12
    10
    11
    13
        ADA-positive at baseline
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    2
    0
    1
    1
    1
        ADA-negative post-baseline
    3
    1
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    5
    5
    0
    2
    0
    0
    3
    1
    10
    0
    1
    0
    0
    8
    5
    2
    1
    0
        ADA- inconclusive post-baseline
    3
    7
    14
    5
    2
    3
    6
    2
    2
    6
    5
    6
    0
    7
    3
    2
    4
    4
    2
    1
    2
    4
    3
    6
    2
    2
    7
    10
    10
    14
        Treatment-induced ADA-positive
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    1
    1
    1
    0
    0
    1
    0
    0
    1
    1
    0
    0
    1
    1
    0
    1
    0
        Treatment-boosted ADA-positive
    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
    Notes
    [185] - n=8 (baseline), 8 (post-baseline)
    [186] - n=8 (baseline), 8 (post-baseline)
    [187] - n=14 (baseline), 14 (post-baseline)
    [188] - n=5 (baseline), 5 (post-baseline)
    [189] - n=2 (baseline), 2 (post-baseline)
    [190] - n=4 (baseline), 4 (post-baseline)
    [191] - n=6 (baseline), 6 (post-baseline)
    [192] - n=2 (baseline), 2 (post-baseline)
    [193] - n=5 (baseline), 5 (post-baseline)
    [194] - n=7 (baseline), 7 (post-baseline)
    [195] - n=5 (baseline), 5 (post-baseline)
    [196] - n=6 (baseline), 6 (post-baseline)
    [197] - n=6 (baseline), 6 (post-baseline)
    [198] - n=12 (baseline), 13 (post-baseline)
    [199] - n=5 (baseline), 4 (post-baseline)
    [200] - n=5 (baseline), 5 (post-baseline)
    [201] - n=4 (baseline), 4 (post-baseline)
    [202] - n=5 (baseline), 4 (post-baseline)
    [203] - n=5 (baseline), 6 (post-baseline)
    [204] - n=2 (baseline), 2 (post-baseline)
    [205] - n=12 (baseline), 12 (post-baseline)
    [206] - n=5 (baseline), 5 (post-baseline)
    [207] - n=4 (baseline), 5 (post-baseline)
    [208] - n=6 (baseline), 6 (post-baseline)
    [209] - n=1 (baseline), 2 (post-baseline)
    [210] - n=11 (baseline), 11 (post-baseline)
    [211] - n=12 (baseline), 13 (post-baseline)
    [212] - n=11 (baseline), 12 (post-baseline)
    [213] - n=12 (baseline), 13 (post-baseline)
    [214] - n=14 (baseline), 14 (post-baseline)
    No statistical analyses for this end point

    Secondary: Number of participants with anti-spartalizumab antibodies

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    End point title
    		 Number of participants with anti-spartalizumab antibodies [215]
    End point description
    Immunogenicity was evaluated in serum in a validated three-tiered assay approach. Samples were screened for potential anti-spartalizumab antibodies and positive screen results were confirmed using a confirmatory assay. For confirmed anti-drug antibodies (ADA) positive samples, titers were determined. Patient ADA status was defined as follows: • ADA-negative at baseline: ADA-negative sample at baseline • ADA-positive at baseline: ADA-positive sample at baseline • ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples • ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative • Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample • Treatment-boosted ADA-positive = ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
    End point type
    Secondary
    End point timeframe
    Baseline (before first dose) and post-baseline (assessed throughout the treatment up to 4.9 years).
    Notes
    [215] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to MBG453+PDR001 arms
    End point values
    		 Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    5 [216]
    12 [217]
    5 [218]
    5 [219]
    4 [220]
    5 [221]
    6 [222]
    2 [223]
    11 [224]
    5 [225]
    4 [226]
    6 [227]
    3 [228]
    13 [229]
    13 [230]
    Units: participants
        ADA-negative at baseline
    4
    9
    3
    5
    4
    4
    5
    2
    9
    4
    3
    6
    3
    12
    13
        ADA-positive at baseline
    0
    3
    1
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
        ADA-negative post-baseline
    2
    7
    2
    4
    3
    1
    3
    1
    7
    3
    2
    4
    2
    6
    7
        ADA- inconclusive post-baseline
    1
    1
    2
    1
    1
    4
    1
    1
    2
    2
    2
    1
    1
    6
    6
        Treatment-induced ADA-positive
    2
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    1
    0
        Treatment-boosted ADA-positive
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Notes
    [216] - n=4 (baseline), 5 (post-baseline)
    [217] - n=12 (baseline), 10 (post-baseline)
    [218] - n=4 (baseline), 5 (post-baseline)
    [219] - n=5 (baseline), 5 (post-baseline)
    [220] - n=4 (baseline), 4 (post-baseline)
    [221] - n=5 (baseline), 5 (post-baseline)
    [222] - n=6 (baseline), 5 (post-baseline)
    [223] - n=2 (baseline), 2 (post-baseline)
    [224] - n=10 (baseline), 11 (post-baseline)
    [225] - n=4 (baseline), 5 (post-baseline)
    [226] - n=3 (baseline), 4 (post-baseline)
    [227] - n=6 (baseline), 6 (post-baseline)
    [228] - n=3 (baseline), 3 (post-baseline)
    [229] - n=12 (baseline), 13 (post-baseline)
    [230] - n=13 (baseline), 13 (post-baseline)
    No statistical analyses for this end point

    Secondary: Baseline expression of PD-L1

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    End point title
    		 Baseline expression of PD-L1
    End point description
    The tumor expression of programmed cell death-ligand 1 (PD-L1) was measured by immunohistochemical methods. This record summarizes the baseline expression of PD-1 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Screening
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    8 [231]
    5 [232]
    9 [233]
    5 [234]
    2 [235]
    4 [236]
    5 [237]
    2 [238]
    4 [239]
    3 [240]
    3 [241]
    6 [242]
    5 [243]
    9 [244]
    4 [245]
    4 [246]
    4 [247]
    3 [248]
    4 [249]
    1 [250]
    11 [251]
    3 [252]
    4 [253]
    6 [254]
    3 [255]
    11 [256]
    14 [257]
    11 [258]
    10 [259]
    14 [260]
    Units: PD-L1 positivity percentage
    median (full range (min-max))
        Clinical benefit
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 5.0)
    999 (999 to 999)
    999 (999 to 999)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    999 (999 to 999)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    999 (999 to 999)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 10.0)
    1.25 (0.0 to 80.0)
    0.00 (0.0 to 0.0)
    999 (999 to 999)
    5.00 (5.0 to 5.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    999 (999 to 999)
    10.00 (0.0 to 90.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 1.0)
    0.00 (0.0 to 35.0)
    999 (999 to 999)
    0.00 (0.0 to 0.5)
    22.50 (5.0 to 40.0)
    0.00 (0.0 to 1.0)
    80.0 (0.0 to 100.0)
    7.75 (0.5 to 15.0)
        No clinical benefit
    0.00 (0.0 to 45.0)
    5.00 (0.0 to 80.0)
    0.00 (0.0 to 90.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    2.50 (0.0 to 5.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 90.0)
    0.00 (0.0 to 20.0)
    5.00 (5.0 to 5.0)
    0.50 (0.0 to 70.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 1.0)
    0.00 (0.0 to 0.0)
    2.50 (0.0 to 5.0)
    5.00 (0.0 to 10.0)
    40.00 (40.0 to 40.0)
    0.00 (0.0 to 80.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    0.00 (0.0 to 0.0)
    60.00 (5.0 to 70.0)
    0.00 (0.0 to 5.0)
    0.00 (0.0 to 1.0)
    0.00 (0.0 to 10.0)
    50.0 (0.0 to 100.0)
    1.00 (0.0 to 50.0)
    Notes
    [231] - n= 2 (benefit), 6 (no benefit)
    [232] - n= 2 (benefit), 3 (no benefit)
    [233] - n= 4 (benefit), 5 (no benefit)
    [234] - n= 0 (benefit), 5 (no benefit)
    [235] - n= 0 (benefit), 2 (no benefit)
    [236] - n= 1 (benefit), 3 (no benefit)
    [237] - n= 1 (benefit), 4 (no benefit)
    [238] - n= 0 (benefit), 2 (no benefit)
    [239] - n= 1 (benefit), 3 (no benefit)
    [240] - n= 1 (benefit), 2 (no benefit)
    [241] - n= 0 (benefit), 3 (no benefit)
    [242] - n= 3 (benefit), 3 (no benefit)
    [243] - n= 4 (benefit), 1 (no benefit)
    [244] - n= 6 (benefit), 3 (no benefit)
    [245] - n= 1 (benefit), 3 (no benefit)
    [246] - n= 0 (benefit), 4 (no benefit)
    [247] - n= 1 (benefit), 3 (no benefit)
    [248] - n= 1 (benefit), 2 (no benefit)
    [249] - n= 2 (benefit), 2 (no benefit)
    [250] - n= 0 (benefit), 1 (no benefit)
    [251] - n= 4 (benefit), 7 (no benefit)
    [252] - n= 2 (benefit), 1 (no benefit)
    [253] - n= 3 (benefit), 1 (no benefit)
    [254] - n= 3 (benefit), 3 (no benefit)
    [255] - n= 0 (benefit), 3 (no benefit)
    [256] - n= 4 (benefit), 7 (no benefit)
    [257] - n= 2 (benefit), 12 (no benefit)
    [258] - n= 4 (benefit), 7 (no benefit)
    [259] - n= 5 (benefit), 5 (no benefit)
    [260] - n= 2 (benefit), 12 (no benefit)
    No statistical analyses for this end point

    Secondary: Baseline expression of CD8+

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    End point title
    		 Baseline expression of CD8+
    End point description
    The tumor expression of CD8+ was measured by immunohistochemical methods. This record summarizes the baseline expression of CD8+ and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Screening
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    8 [261]
    8 [262]
    12 [263]
    5 [264]
    2 [265]
    4 [266]
    4 [267]
    2 [268]
    4 [269]
    3 [270]
    3 [271]
    5 [272]
    6 [273]
    8 [274]
    4 [275]
    4 [276]
    4 [277]
    3 [278]
    4 [279]
    1 [280]
    10 [281]
    2 [282]
    3 [283]
    6 [284]
    3 [285]
    11 [286]
    14 [287]
    11 [288]
    10 [289]
    10 [290]
    Units: percent marker area expression of CD8+
    median (full range (min-max))
        Clinical benefit
    0.35 (0.1 to 2.0)
    0.35 (0.0 to 0.7)
    0.73 (0.3 to 35.8)
    999 (999 to 999)
    999 (999 to 999)
    1.00 (1.0 to 1.0)
    5.54 (5.54 to 5.54)
    999 (999 to 999)
    0.04 (0.0 to 0.1)
    0.01 (0.01 to 0.01)
    999 (999 to 999)
    0.26 (0.2 to 1.4)
    0.47 (0.2 to 3.6)
    2.07 (0.2 to 22.4)
    0.09 (0.09 to 0.09)
    999 (999 to 999)
    8.32 (8.32 to 8.32)
    0.03 (0.03 to 0.03)
    0.08 (0.0 to 0.1)
    999 (999 to 999)
    0.60 (0.0 to 54.0)
    3.81 (2.7 to 4.9)
    3.87 (0.1 to 7.7)
    0.55 (0.1 to 8.3)
    999 (999 to 999)
    0.90 (0.3 to 1.3)
    0.60 (0.6 to 0.6)
    0.11 (0.0 to 0.6)
    7.08 (0.4 to 10.7)
    6.67 (6.67 to 6.67)
        No clinical benefit
    2.17 (0.2 to 21.5)
    0.90 (0.2 to 1.4)
    0.13 (0.0 to 13.2)
    0.65 (0.5 to 0.7)
    4.28 (2.1 to 6.5)
    0.21 (0.0 to 4.3)
    0.37 (0.2 to 3.0)
    0.68 (0.0 to 1.3)
    0.29 (0.1 to 0.5)
    0.22 (0.1 to 0.3)
    0.55 (0.3 to 3.1)
    0.11 (0.11 to 0.11)
    4.76 (4.76 to 4.76)
    4.58 (3.6 to 6.2)
    1.25 (0.0 to 2.9)
    0.42 (0.0 to 7.7)
    0.16 (0.1 to 0.3)
    3.56 (2.9 to 4.3)
    0.10 (0.1 to 0.1)
    0.96 (0.96 to 0.96)
    0.59 (0.1 to 5.3)
    999 (999 to 999)
    0.18 (0.18 to 0.18)
    0.12 (0.1 to 0.2)
    0.11 (0.1 to 0.2)
    0.16 (0.1 to 7.5)
    0.71 (0.1 to 4.2)
    0.38 (0.0 to 1.0)
    3.36 (0.8 to 4.5)
    3.47 (0.2 to 10.0)
    Notes
    [261] - n= 3 (benefit), 5 (no benefit)
    [262] - n= 2 (benefit), 6 (no benefit)
    [263] - n= 6 (benefit), 6 (no benefit)
    [264] - n= 0 (benefit), 5 (no benefit)
    [265] - n= 0 (benefit), 2 (no benefit)
    [266] - n= 1 (benefit), 3 (no benefit))
    [267] - n= 1 (benefit), 3 (no benefit)
    [268] - n= 0 (benefit), 2 (no benefit)
    [269] - n= 2 (benefit), 2 (no benefit)
    [270] - n= 1 (benefit), 2 (no benefit)
    [271] - n= 0 (benefit), 3 (no benefit)
    [272] - n= 3 (benefit), 2 (no benefit)
    [273] - n= 5 (benefit), 1 (no benefit)
    [274] - n= 5 (benefit), 3 (no benefit)
    [275] - n= 1 (benefit), 3 (no benefit)
    [276] - n= 0 (benefit), 4 (no benefit)
    [277] - n= 1 (benefit), 3 (no benefit)
    [278] - n= 1 (benefit), 2 (no benefit)
    [279] - n= 2 (benefit), 2 (no benefit)
    [280] - n= 0 (benefit), 1 (no benefit)
    [281] - n= 3 (benefit), 7 (no benefit)
    [282] - n= 2 (benefit), 0 (no benefit)
    [283] - n= 2 (benefit), 1 (no benefit)
    [284] - n= 3 (benefit), 3 (no benefit)
    [285] - n= 0 (benefit), 3 (no benefit)
    [286] - n= 4 (benefit), 7 (no benefit)
    [287] - n= 2 (benefit), 12 (no benefit)
    [288] - n= 4 (benefit), 7 (no benefit))
    [289] - n= 5 (benefit), 5 (no benefit)
    [290] - n= 1 (benefit), 9 (no benefit)
    No statistical analyses for this end point

    Secondary: Baseline expression of TIM-3

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    End point title
    		 Baseline expression of TIM-3
    End point description
    The tumor expression of T-cell Immunoglobulin domain and Mucin domain-3 (TIM-3) was measured by immunohistochemical methods. This record summarizes the baseline expression of TIM-3 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Screening
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    8 [291]
    4 [292]
    9 [293]
    4 [294]
    2 [295]
    3 [296]
    5 [297]
    2 [298]
    2 [299]
    3 [300]
    3 [301]
    6 [302]
    5 [303]
    8 [304]
    4 [305]
    4 [306]
    3 [307]
    3 [308]
    4 [309]
    1 [310]
    10 [311]
    3 [312]
    4 [313]
    6 [314]
    2 [315]
    11 [316]
    14 [317]
    11 [318]
    9 [319]
    10 [320]
    Units: percent marker area expression of TIM-3
    median (full range (min-max))
        Clinical benefit
    3.01 (0.0 to 6.0)
    2.56 (2.56 to 2.6)
    6.68 (0.6 to 51.3)
    999 (999 to 999)
    999 (999 to 999)
    6.06 (6.06 to 6.06)
    41.00 (41.0 to 41.0)
    999 (999 to 999)
    999 (999 to 999)
    1.05 (1.05 to 1.05)
    999 (999 to 999)
    6.26 (1.7 to 14.2)
    4.19 (0.3 to 6.5)
    15.19 (3.4 to 64.0)
    0.04 (0.04 to 0.04)
    999 (999 to 999)
    999 (999 to 999)
    0.66 (0.66 to 0.66)
    0.40 (0.2 to 0.6)
    999 (999 to 999)
    7.13 (1.3 to 8.1)
    17.81 (8.9 to 26.8)
    11.27 (0.9 to 12.4)
    14.57 (0.7 to 20.3)
    999 (999 to 999)
    5.05 (1.5 to 8.6)
    2.32 (0.9 to 3.7)
    1.66 (0.1 to 8.4)
    7.78 (2.5 to 21.8)
    28.92 (28.92 to 28.92)
        No clinical benefit
    9.32 (0.1 to 49.2)
    6.10 (4.0 to 30.3)
    3.96 (1.2 to 28.9)
    0.99 (0.5 to 2.5)
    10.93 (7.2 to 14.7)
    0.88 (0.4 to 1.3)
    6.74 (1.3 to 10.9)
    5.49 (1.6 to 9.4)
    4.82 (0.7 to 8.9)
    2.70 (0.0 to 5.4)
    15.88 (1.4 to 20.7)
    2.36 (0.3 to 4.0)
    32.23 (32.23 to 32.23)
    47.27 (11.6 to 67.6)
    11.29 (0.5 to 30.1)
    7.27 (0.8 to 20.8)
    1.89 (0.3 to 11.3)
    8.92 (8.1 to 9.7)
    2.13 (0.2 to 4.1)
    52.24 (52.24 to 52.24)
    6.74 (3.5 to 17.2)
    0.84 (0.84 to 0.84)
    0.37 (0.37 to 0.37)
    2.88 (1.1 to 7.1)
    0.71 (0.6 to 0.8)
    1.50 (1.2 to 12.3)
    2.16 (0.1 to 22.9)
    6.20 (0.7 to 19.7)
    8.19 (6.7 to 28.0)
    3.11 (0.6 to 17.7)
    Notes
    [291] - n= 2 (benefit), 6 (no benefit)
    [292] - n= 2 (benefit), 3 (no benefit)
    [293] - n= 4 (benefit), 5 (no benefit)
    [294] - n= 0 (benefit), 4 (no benefit)
    [295] - n= 0 (benefit), 2 (no benefit)
    [296] - n= 1 (benefit), 2 (no benefit)
    [297] - n= 1 (benefit), 4 (no benefit)
    [298] - n= 0 (benefit), 2 (no benefit)
    [299] - n= 0 (benefit), 2 (no benefit)
    [300] - n= 1 (benefit), 2 (no benefit)
    [301] - n= 0 (benefit), 3 (no benefit)
    [302] - n= 3 (benefit), 3 (no benefit)
    [303] - n= 4 (benefit), 1 (no benefit)
    [304] - n= 5 (benefit), 3 (no benefit)
    [305] - n= 1 (benefit), 3 (no benefit)
    [306] - n= 0 (benefit), 4 (no benefit)
    [307] - n= 0 (benefit), 3 (no benefit)
    [308] - n= 1 (benefit), 2 (no benefit)
    [309] - n= 2 (benefit), 2 (no benefit)
    [310] - n= 0 (benefit), 1 (no benefit)
    [311] - n= 3 (benefit), 7 (no benefit)
    [312] - n= 2 (benefit), 1 (no benefit)
    [313] - n= 3 (benefit), 1 (no benefit)
    [314] - n= 3 (benefit), 3 (no benefit)
    [315] - n= 0 (benefit), 2 (no benefit)
    [316] - n= 4 (benefit), 7 (no benefit)
    [317] - n= 2 (benefit), 12 (no benefit)
    [318] - n= 4 (benefit), 7 (no benefit)
    [319] - n= 4 (benefit), 5 (no benefit)
    [320] - n= 1 (benefit), 9 (no benefit)
    No statistical analyses for this end point

    Secondary: Baseline expression of LAG-3

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    End point title
    		 Baseline expression of LAG-3
    End point description
    The tumor expression of lymphocyte-activation gene-3 (LAG-3) was measured by immunohistochemical methods. This record summarizes the baseline expression of LAG-3 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Screening
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    8 [321]
    4 [322]
    8 [323]
    4 [324]
    2 [325]
    3 [326]
    4 [327]
    2 [328]
    3 [329]
    2 [330]
    3 [331]
    6 [332]
    5 [333]
    8 [334]
    4 [335]
    4 [336]
    3 [337]
    3 [338]
    4 [339]
    1 [340]
    10 [341]
    2 [342]
    4 [343]
    6 [344]
    3 [345]
    11 [346]
    12 [347]
    11 [348]
    10 [349]
    12 [350]
    Units: percent marker area expression of LAG-3
    median (full range (min-max))
        Clinical benefit
    0.24 (0.0 to 0.5)
    0.08 (0.08 to 0.8)
    0.23 (0.0 to 26.2)
    999 (999 to 999)
    999 (999 to 999)
    1.30 (1.3 to 1.3)
    7.12 (7.12 to 7.12)
    999 (999 to 999)
    0.03 (0.03 to 0.03)
    999 (999 to 999)
    999 (999 to 999)
    0.02 (0.0 to 0.3)
    0.31 (0.3 to 0.4)
    2.44 (0.0 to 32.1)
    0.00 (0.0 to 0.0)
    999 (999 to 999)
    999 (999 to 999)
    0.01 (0.01 to 0.01)
    0.01 (0.0 to 0.01)
    999 (999 to 999)
    0.20 (0.1 to 0.2)
    2.08 (2.08 to 2.08)
    0.31 (0.0 to 1.7)
    0.83 (0.0 to 4.2)
    999 (999 to 999)
    0.35 (0.1 to 1.1)
    0.16 (0.1 to 0.3)
    0.04 (0.0 to 0.5)
    3.08 (0.2 to 19.0)
    3.39 (3.39 to 3.39)
        No clinical benefit
    1.61 (0.1 to 21.0)
    0.69 (0.4 to 4.8)
    2.68 (0.0 to 29.5)
    0.11 (0.0 to 0.3)
    2.11 (1.0 to 3.2)
    0.02 (0.01 to 0.02)
    0.14 (0.0 to 1.5)
    0.58 (0.0 to 1.2)
    0.10 (0.0 to 0.2)
    0.05 (0.0 to 0.1)
    0.18 (0.18 to 2.4)
    0.06 (0.0 to 0.1)
    7.63 (7.63 to 7.63)
    1.49 (0.9 to 6.2)
    0.78 (0.0 to 1.8)
    0.30 (0.1 to 2.4)
    0.05 (0.0 to 0.2)
    1.33 (1.1 to 1.6)
    0.07 (0.0 to 0.1)
    0.08 (0.08 to 0.08)
    0.33 (0.0 to 4.7)
    0.00 (0.0 to 0.0)
    0.05 (0.05 to 0.05)
    0.06 (0.0 to 0.1)
    0.03 (0.0 to 0.1)
    0.04 (0.0 to 4.0)
    0.43 (0.0 to 1.3)
    0.06 (0.0 to 0.8)
    1.98 (0.4 to 2.5)
    0.57 (0.0 to 10.0)
    Notes
    [321] - n= 2 (benefit), 6 (no benefit)
    [322] - n= 1 (benefit), 3 (no benefit)
    [323] - n= 4 (benefit), 4 (no benefit)
    [324] - n= 0 (benefit), 4 (no benefit)
    [325] - n= 0 (benefit), 2 (no benefit)
    [326] - n= 1 (benefit), 2 (no benefit)
    [327] - n= 1 (benefit), 3 (no benefit)
    [328] - n= 0 (benefit), 2 (no benefit)
    [329] - n= 1 (benefit), 2 (no benefit)
    [330] - n= 0 (benefit), 2 (no benefit)
    [331] - n= 0 (benefit), 3 (no benefit)
    [332] - n= 3 (benefit), 3 (no benefit)
    [333] - n= 4 (benefit), 1 (no benefit)
    [334] - n= 5 (benefit), 3 (no benefit)
    [335] - n= 1 (benefit), 3 (no benefit)
    [336] - n= 0 (benefit), 4 (no benefit)
    [337] - n= 0 (benefit), 3 (no benefit)
    [338] - n= 1 (benefit), 2 (no benefit)
    [339] - n= 2 (benefit), 2 (no benefit)
    [340] - n= 0 (benefit), 1 (no benefit)
    [341] - n= 3 (benefit), 7 (no benefit)
    [342] - n= 1 (benefit), 1 (no benefit)
    [343] - n= 3 (benefit), 1 (no benefit)
    [344] - n= 3 (benefit), 3 (no benefit)
    [345] - n= 0 (benefit), 3 (no benefit)
    [346] - n= 4 (benefit), 7 (no benefit)
    [347] - n= 2 (benefit), 10 (no benefit)
    [348] - n= 4 (benefit), 7 (no benefit)
    [349] - n= 5 (benefit), 5 (no benefit)
    [350] - n= 1 (benefit), 11 (no benefit)
    No statistical analyses for this end point

    Secondary: Baseline expression of CD163

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    End point title
    		 Baseline expression of CD163
    End point description
    The tumor expression of CD163 was measured by immunohistochemical methods. This record summarizes the baseline expression of CD163 and the clinical benefit of study treatment. Clinical benefit (BOR: CR, PR, SD or NCRNPD) and No clinical benefit (BOR: PD) was based on local investigator assessment per RECIST v1.1. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Screening
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    8 [351]
    8 [352]
    13 [353]
    5 [354]
    2 [355]
    3 [356]
    4 [357]
    2 [358]
    4 [359]
    3 [360]
    3 [361]
    6 [362]
    6 [363]
    8 [364]
    4 [365]
    4 [366]
    4 [367]
    3 [368]
    4 [369]
    1 [370]
    10 [371]
    2 [372]
    3 [373]
    6 [374]
    3 [375]
    10 [376]
    12 [377]
    11 [378]
    8 [379]
    10 [380]
    Units: percent marker area expression of CD163
    median (full range (min-max))
        Clinical benefit
    3.12 (1.0 to 20.5)
    0.26 (0.2 to 0.3)
    6.05 (0.5 to 40.2)
    999 (999 to 999)
    999 (999 to 999)
    14.56 (14.56 to 14.56)
    15.47 (15.47 to 15.47)
    999 (999 to 999)
    0.42 (0.3 to 0.6)
    3.79 (3.79 to 3.79)
    999 (999 to 999)
    5.53 (5.4 to 14.0)
    6.76 (1.8 to 10.2)
    21.36 (3.1 to 58.7)
    0.41 (0.41 to 0.41)
    999 (999 to 999)
    12.93 (12.93 to 12.93)
    1.66 (1.66 to 1.66)
    3.44 (2.7 to 4.2)
    999 (999 to 999)
    7.09 (4.2 to 8.9)
    26.40 (26.40 to 26.40)
    12.40 (4.2 to 20.6)
    5.46 (1.5 to 35.8)
    999 (999 to 999)
    5.66 (4.4 to 7.7)
    7.41 (1.8 to 13.1)
    5.41 (0.1 to 13.1)
    16.34 (14.3 to 26.2)
    36.59 (36.59 to 36.59)
        No clinical benefit
    11.53 (4.3 to 36.6)
    9.48 (3.4 to 14.8)
    5.22 (3.2 to 31.3)
    3.92 (0.8 to 4.9)
    7.60 (6.0 to 9.2)
    0.98 (0.9 to 1.0)
    14.30 (7.5 to 15.1)
    3.66 (2.2 to 5.1)
    6.95 (1.6 to 12.3)
    7.36 (1.7 to 13.0)
    19.69 (10.8 to 20.5)
    5.78 (1.9 to 7.7)
    16.17 (16.17 to 16.17)
    26.28 (24.3 to 70.4)
    6.23 (3.3 to 28.2)
    10.36 (4.6 to 289)
    5.08 (1.4 to 33.6)
    11.11 (4.7 to 17.5)
    1.14 (0.6 to 1.7)
    28.64 (28.64 to 28.64)
    10.62 (5.4 to 17.5)
    3.67 (3.67 to 3.67)
    1.41 (1.41 to 1.41)
    3.47 (2.5 to 23.1)
    5.80 (3.9 to 6.1)
    5.78 (0.6 to 18.5)
    4.92 (1.6 to 31.2)
    3.56 (2.0 to 11.6)
    17.46 (10.9 to 26.7)
    11.88 (4.0 to 54.8)
    Notes
    [351] - n= 3 (benefit), 5 (no benefit)
    [352] - n= 2 (benefit), 6 (no benefit)
    [353] - n= 6 (benefit), 7 (no benefit)
    [354] - n= 0 (benefit), 5 (no benefit)
    [355] - n= 0 (benefit), 2 (no benefit)
    [356] - n= 1 (benefit), 2 (no benefit)
    [357] - n= 1 (benefit), 3 (no benefit)
    [358] - n= 0 (benefit), 2 (no benefit)
    [359] - n= 2 (benefit), 2 (no benefit)
    [360] - n= 1 (benefit), 2 (no benefit)
    [361] - n= 0 (benefit), 3 (no benefit)
    [362] - n= 3 (benefit), 3 (no benefit)
    [363] - n= 5 (benefit), 1 (no benefit)
    [364] - n= 5 (benefit), 3 (no benefit)
    [365] - n= 1 (benefit), 3 (no benefit)
    [366] - n= 0 (benefit), 4 (no benefit)
    [367] - n= 1 (benefit), 3 (no benefit)
    [368] - n= 1 (benefit), 2 (no benefit)
    [369] - n= 2 (benefit), 2 (no benefit)
    [370] - n= 0 (benefit), 1 (no benefit)
    [371] - n= 3 (benefit), 7 (no benefit)
    [372] - n= 1 (benefit), 1 (no benefit)
    [373] - n= 2 (benefit), 1 (no benefit)
    [374] - n= 3 (benefit), 3 (no benefit)
    [375] - n= 0 (benefit), 3 (no benefit)
    [376] - n= 4 (benefit), 6 (no benefit)
    [377] - n= 2 (benefit), 10 (no benefit)
    [378] - n= 4 (benefit), 7 (no benefit)
    [379] - n= 4 (benefit), 4 (no benefit)
    [380] - n= 1 (benefit), 9 (no benefit)
    No statistical analyses for this end point

    Secondary: Percentage change from baseline of Tumor Infiltrating Lymphocytes (TILs) count

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    End point title
    		 Percentage change from baseline of Tumor Infiltrating Lymphocytes (TILs) count
    End point description
    The count of TILs was performed by hematoxylin and eosin stain.
    End point type
    Secondary
    End point timeframe
    Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 193 days)
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    2
    2
    6
    0 [381]
    1
    0 [382]
    0 [383]
    0 [384]
    0 [385]
    0 [386]
    0 [387]
    2
    2
    1
    2
    1
    2
    0 [388]
    0 [389]
    1
    1
    0 [390]
    0 [391]
    0 [392]
    0 [393]
    3
    2
    0 [394]
    2
    1
    Units: percentage change from baseline
        median (full range (min-max))
    41.67 (-50.0 to 133.3)
    -100.00 (-100.0 to -100.0)
    -25.00 (-100.0 to 900.0)
    ( to )
    -50.00 (-50.0 to -50.0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    -70.00 (-100.0 to -40.0)
    -75.00 (-100.0 to -50.0)
    -66.67 (-66.67 to -66.67)
    -25.00 (-50.0 to 0.0)
    -50.00 (-50.0 to -50.0)
    -50.00 (-100.0 to 0.0)
    ( to )
    ( to )
    -97.50 (-97.5 to -97.5)
    -87.50 (-87.5 to -87.5)
    ( to )
    ( to )
    ( to )
    ( to )
    -66.67 (-100.0 to 100.0)
    550.00 (200.0 to 900.0)
    ( to )
    -40.95 (-70.1 to -11.8)
    -48.43 (-48.43 to -48.43)
    Notes
    [381] - No values available (n=0)
    [382] - No values available (n=0)
    [383] - No values available (n=0)
    [384] - No values available (n=0)
    [385] - No values available (n=0)
    [386] - No values available (n=0)
    [387] - No values available (n=0)
    [388] - No values available (n=0)
    [389] - No values available (n=0)
    [390] - No values available (n=0)
    [391] - No values available (n=0)
    [392] - No values available (n=0)
    [393] - No values available (n=0)
    [394] - No values available (n=0)
    No statistical analyses for this end point

    Secondary: Phase II: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) during the on-treatment period

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    End point title
    		 Phase II: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) during the on-treatment period [395]
    End point description
    Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication up to 30 days after last dose, with a maximum duration of 3 years
    Notes
    [395] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to Phase II
    End point values
    		 Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    17
    16
    Units: participants
        AEs
    16
    15
        Treatment-related AEs
    6
    9
        AEs with grade ≥ 3
    10
    6
        Treatment-related AEs with grade ≥ 3
    2
    0
        SAEs
    9
    2
        Fatal SAEs
    1
    0
        AEs leading to discontinuation
    2
    1
        AEs leading to dose adjustment/interruption
    4
    0
        AEs requiring additional therapy
    15
    14
    No statistical analyses for this end point

    Secondary: Phase II: Number of participants with dose reductions and dose interruptions of sabatolimab

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    End point title
    		 Phase II: Number of participants with dose reductions and dose interruptions of sabatolimab [396]
    End point description
    Number of participants with at least one dose reduction of sabatolimab and number of participants with at least one dose interruption of sabatolimab.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 2.9 years
    Notes
    [396] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to Phase II
    End point values
    		 Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    17
    16
    Units: participants
        At least one dose reduction
    0
    0
        At least one dose interruption
    3
    0
    No statistical analyses for this end point

    Secondary: Phase II: Dose intensity of sabatolimab

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    End point title
    		 Phase II: Dose intensity of sabatolimab [397]
    End point description
    Dose intensity of sabatolimab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 2.9 years
    Notes
    [397] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to Phase II
    End point values
    		 Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    17
    16
    Units: milligrams
        arithmetic mean (standard deviation)
    772.94 ( 62.826 )
    800.00 ( 0.000 )
    No statistical analyses for this end point

    Secondary: Phase II: Dose intensity of spartalizumab

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    End point title
    		 Phase II: Dose intensity of spartalizumab [398]
    End point description
    Dose intensity of spartalizumab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 2.9 years
    Notes
    [398] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to Phase II
    End point values
    		 Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    17
    16
    Units: milligrams
        arithmetic mean (standard deviation)
    386.47 ( 31.413 )
    400.00 ( 0.000 )
    No statistical analyses for this end point

    Secondary: Phase II: Number of participants with dose reductions and dose interruptions of spartalizumab

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    End point title
    		 Phase II: Number of participants with dose reductions and dose interruptions of spartalizumab [399]
    End point description
    Number of participants with at least one dose reduction of spartalizumab and number of participants with at least one dose interruption of spartalizumab.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication up to last dose, with a maximum duration of 2.9 years
    Notes
    [399] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to Phase II
    End point values
    		 Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    17
    16
    Units: participants
        At least one dose reduction
    0
    0
        At least one dose interruption
    3
    0
    No statistical analyses for this end point

    Post-hoc: All-Collected Deaths

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    End point title
    		 All-Collected Deaths
    End point description
    On-treatment and post-treatment safety follow-up deaths were collected from first dose of study medication to 30 days after last dose (sabatolimab single agent) and to 150 days after last dose (sabatolimab+spartalizumab). Survival follow-up deaths were collected from 31 days (sabatolimab) and 151 days (sabatolimab+spartalizumab) after last dose until end of study. All deaths refer to the sum of on-treatment and post-treatment safety follow-up deaths plus survival follow-up deaths.
    End point type
    Post-hoc
    End point timeframe
    On-treatment and post-treatment safety follow-up (FU) deaths: up to 2 years for sabatolimab and 5.3 years for sabatolimab + spartalizumab. Survival follow-up deaths: up to 2 years for sabatolimab and 5.3 years for sabatolimab + spartalizumab
    End point values
    		 Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mg Q4W Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Dose Ranging Part: MBG453 1200mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase II: MBG453 + PDR001 Melanoma
    Number of subjects analysed
    14 [400]
    9 [401]
    16 [402]
    5 [403]
    2 [404]
    4 [405]
    6 [406]
    2 [407]
    8 [408]
    9 [409]
    6 [410]
    6 [411]
    6 [412]
    13 [413]
    6 [414]
    5 [415]
    5 [416]
    6 [417]
    6 [418]
    3 [419]
    12 [420]
    5 [421]
    7 [422]
    6 [423]
    6 [424]
    14 [425]
    17 [426]
    15 [427]
    17 [428]
    16 [429]
    Units: participants
        On-treatment and post-treatment safety FU deaths
    9
    4
    6
    5
    1
    4
    5
    1
    3
    4
    4
    3
    1
    5
    2
    5
    2
    3
    0
    3
    5
    2
    1
    2
    4
    8
    9
    6
    9
    6
        Survival FU deaths
    3
    4
    7
    0
    1
    0
    1
    1
    3
    3
    1
    3
    2
    4
    3
    0
    2
    2
    2
    0
    6
    2
    3
    2
    1
    4
    3
    7
    8
    7
        All deaths
    12
    8
    13
    5
    2
    4
    6
    2
    6
    7
    5
    6
    3
    9
    5
    5
    4
    5
    2
    3
    11
    4
    4
    4
    5
    12
    12
    13
    17
    13
    Notes
    [400] - n= 14 (on-treatment and safety FU), 5 (survival), 14 (all)
    [401] - n= 9 (on-treatment and safety FU), 5 (survival), 9 (all)
    [402] - n= 16 (on-treatment and safety FU), 10 (survival), 16 (all)
    [403] - n= 5 (on-treatment and safety FU), 0 (survival), 5 (all)
    [404] - n= 2 (on-treatment and safety FU), 1 (survival), 2 (all)
    [405] - n= 4 (on-treatment and safety FU), 0 (survival), 4 (all)
    [406] - n= 6 (on-treatment and safety FU), 1 (survival), 6 (all)
    [407] - n= 2 (on-treatment and safety FU), 1 (survival), 2 (all)
    [408] - n= 8 (on-treatment and safety FU), 5 (survival), 8 (all)
    [409] - n= 9 (on-treatment and safety FU), 5 (survival), 9 (all)
    [410] - n= 6 (on-treatment and safety FU), 2 (survival), 6 (all)
    [411] - n= 6 (on-treatment and safety FU), 3 (survival), 6 (all)
    [412] - n= 6 (on-treatment and safety FU), 5 (survival), 6 (all)
    [413] - n= 13 (on-treatment and safety FU), 8 (survival), 13 (all)
    [414] - n= 6 (on-treatment and safety FU), 4 (survival), 6 (all)
    [415] - n= 5 (on-treatment and safety FU), 0 (survival), 5 (all)
    [416] - n= 5 (on-treatment and safety FU), 3 (survival), 5 (all)
    [417] - n= 6 (on-treatment and safety FU), 3 (survival), 6 (all)
    [418] - n= 6 (on-treatment and safety FU), 6 (survival), 6 (all)
    [419] - n= 3 (on-treatment and safety FU), 0 (survival), 3 (all)
    [420] - n= 12 (on-treatment and safety FU), 7 (survival), 12 (all)
    [421] - n= 5 (on-treatment and safety FU), 3 (survival), 5 (all)
    [422] - n= 7 (on-treatment and safety FU), 6 (survival), 7 (all)
    [423] - n= 6 (on-treatment and safety FU), 4 (survival), 6 (all)
    [424] - n= 6 (on-treatment and safety FU), 2 (survival), 6 (all)
    [425] - n= 14 (on-treatment and safety FU), 6 (survival), 14 (all)
    [426] - n= 17 (on-treatment and safety FU), 8 (survival), 17 (all)
    [427] - n= 15 (on-treatment and safety FU), 9 (survival), 15 (all)
    [428] - n= 17 (on-treatment and safety FU), 8 (survival), 17 (all)
    [429] - n= 16 (on-treatment and safety FU), 10 (survival), 16 (all)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from first dose of study treatment to 30 days after last dose (sabatolimab single agent) and to 150 days after last dose (sabatolimab+spartalizumab), up to 2 years for sabatolimab and 5.3 years for sabatolimab+spartalizumab.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q2W ROW
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q2W ROW
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q2W ROW
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 80mg Q2W ROW
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 80mg Q2W Japan
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q4W ROW
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q4W Japan
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Dose Ranging Part: MBG453 80mg Q4W
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Dose Ranging Part: MBG453 240mg Q4W
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q4W ROW
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q4W ROW
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 1200mg Q2W Japan
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 800mg Q2W Japan
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase I Dose Escalation: MBG453 240mg Q2W Japan
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Dose Ranging Part: MBG453 1200mg Q4W
    Reporting group description
    		 Safety data up to 30 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase II: MBG453 + PDR001 Melanoma
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase II: MBG453 + PDR001 NSCLC
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mgQ4W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Reporting group title
    Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W
    Reporting group description
    		 Safety data up to 150 days after last dose

    Serious adverse events
    		 Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Dose Ranging Part: MBG453 1200mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 Melanoma Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mgQ4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    9 / 16 (56.25%)
    1 / 9 (11.11%)
    6 / 14 (42.86%)
    0 / 2 (0.00%)
    4 / 6 (66.67%)
    0 / 6 (0.00%)
    10 / 14 (71.43%)
    8 / 17 (47.06%)
    6 / 9 (66.67%)
    3 / 8 (37.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    9 / 15 (60.00%)
    7 / 13 (53.85%)
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    5 / 5 (100.00%)
    4 / 5 (80.00%)
    0 / 6 (0.00%)
    4 / 6 (66.67%)
    1 / 3 (33.33%)
    5 / 16 (31.25%)
    3 / 5 (60.00%)
    2 / 7 (28.57%)
    4 / 6 (66.67%)
    9 / 17 (52.94%)
    5 / 6 (83.33%)
    2 / 12 (16.67%)
         number of deaths (all causes)
    5
    6
    4
    9
    1
    4
    3
    8
    9
    4
    3
    1
    5
    4
    6
    5
    1
    2
    5
    2
    3
    0
    3
    6
    2
    1
    2
    9
    4
    5
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 1
    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 / 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
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 neoplasm
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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 / 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
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inferior vena cava syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injection site reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Pelvic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    2 / 17 (11.76%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 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 / 1
    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 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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 / 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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    1 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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 / 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
    Respiratory arrest
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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 / 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
    Wheezing
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart rate increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 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
    Brain oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1 / 1
    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 / 1
    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 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 loss anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    3 / 15 (20.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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 / 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
    Impaired gastric emptying
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    3 / 14 (21.43%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune-mediated hepatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema asteatotic
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 2
    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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningoencephalitis viral
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 1
    0 / 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
    0 / 0
         deaths causally 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Serratia bacteraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Phase I Dose Escalation: MBG453 1200mg Q2W ROW Phase I Dose Escalation: MBG453 800mg Q2W ROW Phase I Dose Escalation: MBG453 240mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W ROW Phase I Dose Escalation: MBG453 80mg Q2W Japan Phase I Dose Escalation: MBG453 1200mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q4W Japan Dose Ranging Part: MBG453 80mg Q4W Dose Ranging Part: MBG453 240mg Q4W Phase I Dose Escalation: MBG453 800mg Q4W ROW Phase I Dose Escalation: MBG453 240mg Q4W ROW Phase I Dose Escalation: MBG453 1200mg Q2W Japan Phase I Dose Escalation: MBG453 800mg Q2W Japan Phase I Dose Escalation: MBG453 240mg Q2W Japan Dose Ranging Part: MBG453 1200mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 20mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 240mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 80mg Q2W Phase Ib Dose Escalation: MBG453 800mg Q2W + PDR001 240mg Q2W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 80mg Q4W Phase Ib Dose Escalation: MBG453 80mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 Melanoma Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 240mg Q4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 400mg Q4W Phase Ib Dose Escalation: MBG453 800mg Q4W + PDR001 400mg Q4W Phase II: MBG453 + PDR001 NSCLC Phase Ib Dose Escalation: MBG453 1200mg Q4W + PDR001 400mgQ4W Phase Ib Dose Escalation: MBG453 240mg Q4W + PDR001 80mg Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    14 / 16 (87.50%)
    9 / 9 (100.00%)
    13 / 14 (92.86%)
    2 / 2 (100.00%)
    5 / 6 (83.33%)
    6 / 6 (100.00%)
    13 / 14 (92.86%)
    17 / 17 (100.00%)
    9 / 9 (100.00%)
    7 / 8 (87.50%)
    2 / 2 (100.00%)
    6 / 6 (100.00%)
    4 / 4 (100.00%)
    14 / 15 (93.33%)
    12 / 13 (92.31%)
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    3 / 3 (100.00%)
    15 / 16 (93.75%)
    5 / 5 (100.00%)
    6 / 7 (85.71%)
    6 / 6 (100.00%)
    17 / 17 (100.00%)
    6 / 6 (100.00%)
    11 / 12 (91.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    3 / 14 (21.43%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Intracranial tumour haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    1
    0
    0
    0
    0
    1
    Tumour invasion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    0
    Tumour associated fever
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Tumour pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    4 / 6 (66.67%)
    2 / 4 (50.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    1
    0
    1
    0
    1
    1
    3
    1
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    Embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    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
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    2 / 14 (14.29%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    2
    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
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Peripheral embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 17 (11.76%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    1
    1
    1
    2
    0
    0
    0
    1
    0
    0
    0
    4
    1
    2
    0
    1
    2
    0
    0
    0
    2
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Axillary pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    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
    Chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    2
    0
    0
    1
    0
    0
    1
    1
    0
    Early satiety
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Face oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Facial pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 5 (40.00%)
    6 / 16 (37.50%)
    5 / 9 (55.56%)
    4 / 14 (28.57%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    4 / 14 (28.57%)
    4 / 17 (23.53%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    4 / 6 (66.67%)
    0 / 4 (0.00%)
    6 / 15 (40.00%)
    7 / 13 (53.85%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    2 / 5 (40.00%)
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 3 (33.33%)
    5 / 16 (31.25%)
    3 / 5 (60.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    3 / 17 (17.65%)
    1 / 6 (16.67%)
    3 / 12 (25.00%)
         occurrences all number
    2
    7
    4
    4
    0
    1
    1
    4
    3
    2
    2
    0
    4
    0
    7
    7
    1
    4
    3
    2
    0
    2
    1
    4
    3
    2
    1
    3
    1
    2
    Generalised oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 13 (15.38%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperpyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Localised oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nodule
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 17 (11.76%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    1
    1
    0
    Oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    2 / 14 (14.29%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    2 / 14 (14.29%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    2 / 2 (100.00%)
    2 / 6 (33.33%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    2 / 13 (15.38%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    2
    2
    1
    1
    1
    1
    2
    1
    0
    2
    1
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    1
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    2
    Pain
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    3
    0
    1
    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
    Swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    2
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    3 / 8 (37.50%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
    4 / 15 (26.67%)
    2 / 13 (15.38%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    4 / 6 (66.67%)
    1 / 3 (33.33%)
    2 / 16 (12.50%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    4 / 17 (23.53%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    2
    0
    1
    4
    0
    20
    1
    4
    1
    3
    0
    3
    0
    1
    4
    1
    2
    1
    0
    0
    4
    1
    0
    Vascular device occlusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Xerosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Social circumstances
    Menopause
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Breast pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Menstruation irregular
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    0
    0
    0
    Pelvic discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Vaginal odour
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Vulvovaginal erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial fistula
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    3 / 9 (33.33%)
    3 / 14 (21.43%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    1 / 15 (6.67%)
    3 / 13 (23.08%)
    4 / 6 (66.67%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    3 / 5 (60.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    3 / 16 (18.75%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    3 / 17 (17.65%)
    1 / 6 (16.67%)
    3 / 12 (25.00%)
         occurrences all number
    0
    3
    3
    2
    1
    1
    0
    1
    1
    1
    1
    0
    0
    2
    1
    3
    6
    2
    0
    5
    0
    2
    0
    4
    1
    2
    0
    4
    1
    4
    Epistaxis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    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
    1
    Dyspnoea
         subjects affected / exposed
    1 / 5 (20.00%)
    4 / 16 (25.00%)
    4 / 9 (44.44%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    3 / 14 (21.43%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    3 / 8 (37.50%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    1 / 4 (25.00%)
    2 / 15 (13.33%)
    3 / 13 (23.08%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    3 / 5 (60.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    3 / 17 (17.65%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    1
    4
    2
    0
    0
    2
    1
    2
    1
    1
    2
    0
    2
    1
    2
    3
    0
    0
    1
    3
    0
    2
    0
    1
    0
    1
    0
    3
    1
    1
    Nasal congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Hypoxia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 17 (11.76%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    1
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    1
    0
    0
    0
    0
    0
    1
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Paranasal sinus hypersecretion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Pulmonary artery aneurysm
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    1
    0
    0
    1
    0
    0
    0
    0
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    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
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    3
    0
    0
    0
    0
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Delirium
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    1
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 17 (11.76%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    1
    1
    2
    0
    0
    1
    1
    0
    0
    2
    1
    1
    Ammonia increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Aspartate aminotransferase
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Amylase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    1
    1
    0
    1
    1
    2
    2
    0
    0
    2
    1
    2
    1
    1
    0
    0
    1
    0
    6
    0
    1
    1
    1
    Blood albumin decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    2 / 9 (22.22%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    2
    0
    0
    2
    1
    1
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Blood calcium increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    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 creatinine increased
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    2 / 2 (100.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    2
    0
    1
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    2
    1
    1
    Blood potassium decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    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
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Coronavirus test positive
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Human chorionic gonadotropin increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    2
    1
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    2 / 14 (14.29%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    2
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    Liver function test increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    1
    0
    0
    0
    Low density lipoprotein increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    Platelet count increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    2
    0
    2
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    2
    0
    0
    0
    0
    0
    Gastroenteritis radiation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Post procedural discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    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
    1
    Radiation skin injury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Wound
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Cardiac disorders
    Atrial thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 17 (11.76%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    2
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Ataxia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Aphasia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    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
    Cranial nerve disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Brain oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dizziness postural
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Diabetic neuropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Facial paralysis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dyskinesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Facial paresis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 16 (18.75%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    2 / 5 (40.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    1
    2
    0
    1
    2
    0
    1
    0
    0
    0
    Hemiparesis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hypoglossal nerve paralysis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    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
    Neuropathy peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         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
    0
    0
    0
    0
    3
    Myasthenia gravis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    0
    Muscle spasticity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    3
    0
    0
    0
    0
    0
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Partial seizures
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Polyneuropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Speech disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Seizure
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    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
    Sciatica
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    2 / 9 (22.22%)
    3 / 14 (21.43%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    1 / 14 (7.14%)
    4 / 17 (23.53%)
    3 / 9 (33.33%)
    3 / 8 (37.50%)
    2 / 2 (100.00%)
    2 / 6 (33.33%)
    0 / 4 (0.00%)
    5 / 15 (33.33%)
    3 / 13 (23.08%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    2 / 3 (66.67%)
    4 / 16 (25.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    4 / 17 (23.53%)
    2 / 6 (33.33%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    2
    3
    0
    1
    5
    1
    4
    5
    4
    1
    3
    0
    8
    3
    1
    2
    1
    1
    0
    1
    2
    3
    1
    1
    1
    6
    2
    2
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    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
    Anaemia of malignant disease
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Neutrophilia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Normocytic anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    1
    0
    0
    0
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Tinnitus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    2
    0
    0
    0
    0
    Cataract
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Eye paraesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Photophobia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    3 / 9 (33.33%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    3 / 17 (17.65%)
    2 / 9 (22.22%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    1 / 13 (7.69%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    3 / 17 (17.65%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    0
    3
    5
    2
    1
    0
    0
    0
    4
    1
    2
    0
    1
    1
    0
    5
    0
    1
    0
    2
    5
    3
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    1 / 13 (7.69%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    3
    0
    0
    1
    1
    0
    0
    0
    2
    Abdominal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    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
    Anal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    0
    0
    2
    1
    0
    0
    0
    1
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    2
    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
    Anal incontinence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Ascites
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 14 (7.14%)
    3 / 17 (17.65%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    4
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cheilitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 16 (18.75%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    3 / 17 (17.65%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    1
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    4 / 16 (25.00%)
    3 / 9 (33.33%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    2 / 14 (14.29%)
    3 / 17 (17.65%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    3 / 17 (17.65%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    5
    1
    3
    0
    0
    1
    2
    3
    1
    1
    0
    0
    0
    1
    3
    2
    0
    1
    1
    3
    4
    0
    1
    3
    0
    3
    4
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 16 (12.50%)
    3 / 9 (33.33%)
    2 / 14 (14.29%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    4 / 14 (28.57%)
    4 / 17 (23.53%)
    0 / 9 (0.00%)
    4 / 8 (50.00%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    3 / 13 (23.08%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    1 / 3 (33.33%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    5 / 17 (29.41%)
    0 / 6 (0.00%)
    4 / 12 (33.33%)
         occurrences all number
    1
    2
    2
    2
    1
    1
    0
    4
    4
    0
    4
    1
    1
    0
    2
    3
    1
    3
    0
    1
    0
    5
    1
    1
    0
    1
    1
    5
    0
    4
    Gastritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Ileus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Large intestinal stenosis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    5 / 16 (31.25%)
    1 / 9 (11.11%)
    5 / 14 (35.71%)
    0 / 2 (0.00%)
    3 / 6 (50.00%)
    1 / 6 (16.67%)
    4 / 14 (28.57%)
    3 / 17 (17.65%)
    3 / 9 (33.33%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    5 / 6 (83.33%)
    0 / 4 (0.00%)
    3 / 15 (20.00%)
    2 / 13 (15.38%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    1 / 3 (33.33%)
    5 / 16 (31.25%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    3 / 17 (17.65%)
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    7
    3
    4
    0
    3
    0
    5
    3
    3
    1
    1
    3
    0
    4
    2
    0
    1
    1
    0
    1
    4
    1
    6
    1
    0
    2
    3
    0
    2
    Mouth ulceration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Oral discharge
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Rectal tenesmus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    5
    0
    1
    0
    0
    0
    2
    0
    0
    Toothache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 16 (18.75%)
    2 / 9 (22.22%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    4 / 17 (23.53%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    3 / 13 (23.08%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    1 / 3 (33.33%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    2 / 17 (11.76%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    6
    3
    1
    0
    0
    0
    4
    9
    2
    0
    0
    1
    0
    0
    2
    0
    0
    1
    0
    0
    5
    1
    3
    0
    0
    2
    2
    0
    0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatic failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Hepatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    0
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    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
    0
    Jaundice
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    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
    Liver disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 6 (50.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    2 / 6 (33.33%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    1
    0
    Drug eruption
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    2
    Ecchymosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hidradenitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    1
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Lichenoid keratosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    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
    Pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    1 / 17 (5.88%)
    2 / 6 (33.33%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    2
    1
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    1
    0
    2
    0
    2
    3
    1
    2
    2
    Psoriasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    1
    0
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    2 / 6 (33.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    1
    3
    0
    0
    2
    1
    1
    2
    0
    2
    0
    0
    1
    0
    2
    0
    Rash pruritic
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Rash vesicular
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Skin irritation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vitiligo
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Bladder spasm
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    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
    Hydronephrosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    1
    0
    0
    1
    0
    0
    0
    Chromaturia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Incontinence
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Renal disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 13 (15.38%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Strangury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Cushing's syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    2
    0
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    2 / 5 (40.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Hypopituitarism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 16 (0.00%)
    2 / 9 (22.22%)
    3 / 14 (21.43%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    4 / 17 (23.53%)
    2 / 6 (33.33%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    2
    3
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    4
    2
    0
    0
    3
    0
    0
    0
    2
    2
    0
    1
    4
    2
    3
    Bone pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Bone cyst
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    3 / 5 (60.00%)
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    2 / 6 (33.33%)
    2 / 17 (11.76%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    2
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    3
    2
    0
    0
    3
    2
    2
    0
    0
    0
    1
    2
    2
    1
    0
    Bursitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Coccydynia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Fracture pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Hypercreatinaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Gouty arthritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    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
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    1
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    1 / 6 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    4
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Myositis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    2 / 5 (40.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    2
    0
    1
    0
    0
    1
    Polyarthritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Periarthritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    1
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Sacral pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Spinal stenosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Infections and infestations
    Aerococcus urinae infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatophytosis of nail
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hepatitis B reactivation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    2 / 6 (33.33%)
    0 / 12 (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
    1
    0
    0
    0
    0
    2
    0
    Influenza
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    1
    Infected cyst
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Kidney infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Lip infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Mucosal infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    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
    1
    0
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Parotitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    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
    Pneumonia aspiration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    1
    0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Tinea infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Upper aerodigestive tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 14 (14.29%)
    1 / 17 (5.88%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 13 (15.38%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    1
    1
    0
    0
    2
    0
    0
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (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
    0
    0
    0
    1
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Wound infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    6 / 14 (42.86%)
    0 / 2 (0.00%)
    3 / 6 (50.00%)
    3 / 6 (50.00%)
    1 / 14 (7.14%)
    4 / 17 (23.53%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    4 / 6 (66.67%)
    2 / 4 (50.00%)
    2 / 15 (13.33%)
    2 / 13 (15.38%)
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    3 / 16 (18.75%)
    2 / 5 (40.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    0
    5
    0
    2
    3
    1
    4
    1
    1
    1
    1
    2
    2
    2
    1
    2
    1
    1
    0
    1
    1
    2
    2
    0
    2
    1
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    2
    Diabetes mellitus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    1
    0
    0
    Folate deficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    2 / 13 (15.38%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    2
    2
    0
    0
    2
    0
    0
    1
    1
    0
    0
    0
    1
    3
    1
    1
    2
    0
    0
    2
    0
    0
    0
    4
    0
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Hypermagnesaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    3
    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
    Hypernatraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    3 / 17 (17.65%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    1 / 6 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    4
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         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
    0
    1
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    2
    1
    0
    0
    0
    0
    0
    0
    1
    4
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    1
    0
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    5 / 14 (35.71%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    7
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    2 / 6 (33.33%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    3
    0
    0
    0
    Hypovitaminosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    1
    0
    0
    Hypouricaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    1 / 17 (5.88%)
    0 / 6 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    3
    1
    1
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 13 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 17 (0.00%)
    0 / 6 (0.00%)
    0 / 12 (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
    0
    0
    0
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2015
    This amendment addressed the following revisions requested by a regulatory authority: • Clarification in protocol to require discontinuation of study drug for Grade 3 treatment-related cardiac adverse events and for grade 3 treatment-related neurological events. • To include assessment of vital signs during infusion of study drug as well as after. In addition, include requirements to observe subjects for 1-2 hours post infusion of study drug. • Clarification of wording in protocol to provide additional details concerning dose escalation decision and number of subjects to include in the first cohort.
    06 Jun 2016
    The main purpose of this amendment was to include a Japanese dose escalation part for single-agent sabatolimab with the goal of informing subsequent clinical development opportunities in Japan.
    18 Jul 2016
    The purpose of this amendment was to update the exclusion criterion 2 as requested by a regulatory authority. The exclusion criterion was modified to clarify that subjects with a history of hypersensitivity to any ingredient of the study drugs are also excluded.
    04 Sep 2018
    The purpose of this amendment was to incorporate health authority-requested language requiring study treatment discontinuation in the event of Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN).
    04 Nov 2019
    The main purpose of this amendment was to explore a new treatment arm of sabatolimab in combination with decitabine with the option, at disease progression, to add spartalizumab in anti-PD-1/PD-L1 therapy naïve small cell lung cancer (SCLC) subjects who have failed no more than two lines of standard chemotherapy including topotecan.
    31 Aug 2020
    The main purpose of this amendment is to communicate the decision by Novartis to not open enrolment in the SCLC arm for Sabatolimab in combination with decitabine. Importantly, this decision is made due to the rapidly evolving treatment landscape for SCLC patients and is not a consequence of any safety concern. In addition, the definition of end of study was revised to include the option for patients still on study treatment and who, in the opinion of the investigator, are still deriving clinical benefit at the time of end of study, to transfer to another study or to an alternative treatment option to continue providing study treatment to these patients. The objective/endpoint to assess the pharmacodynamic effect of Sabatolimab as a single agent or Sabatolimab in combination with Spartalizumab or in combination with decitabine in tumor samples using RNA/protein was switched from a secondary to an exploratory objective/endpoint as this objective was hypothesis-generating only.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/#/
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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