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    Clinical Trial Results:
    A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects with Select Advanced Solid Tumors

    Summary
    EudraCT number
    		 2016-000662-38
    Trial protocol
    		 GB   HU   ES   FR   BE   IT  
    Global end of trial date
    26 Oct 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Feb 2023
    First version publication date
    06 Nov 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D419NC00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02671435
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, Maryland, United States, 20878
    Public contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 877-240-9479, information.center@astrazeneca.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
    22 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To assess safety and tolerability, describe dose-limiting toxicities (DLTs), and determine maximum tolerated dose (MTD) of durvalumab in combination with monalizumab in subjects with advanced solid tumors and with select advanced solid tumors. 2. To assess safety and tolerability of durvalumab in combination with monalizumab plus chemotherapy with or without a biologic agent (bevacizumab or cetuximab), in subjects with first line (1L) or second line (2L) MSS-CRC. 3. To assess safety (C1A, C2A) and tolerability (C1A and C2A), and evaluate the preliminary antitumor activity (C1A only) of durvalumab in combination with monalizumab plus cetuximab in subjects with 3L MSS-CRC that is RAS mutant (C1A) or RAS/BRAF wild type (C2A). 4. To assess safety (C1B, C2B) and tolerability (C1B and C2B), and evaluate the preliminary antitumor activity (C1B only) of monalizumab in combination with cetuximab in subjects with 3L MSS-CRC that is RAS mutant (C1B) or RAS/BRAF wild type (C2B).
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed an informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2016
    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
    Australia: 3
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    New Zealand: 7
    Country: Number of subjects enrolled
    Korea, Republic of: 40
    Country: Number of subjects enrolled
    Spain: 62
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    United States: 219
    Worldwide total number of subjects
    383
    EEA total number of subjects
    87
    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)
    268
    From 65 to 84 years
    115
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at study sites located in North America, Europe, and Asia Pacific, across 47 sites and 11 countries (Australia, Belgium, Canada, France, Hungary, Italy, New Zealand, South Korea, Spain, United Kingdom, and United States).

    Pre-assignment
    Screening details
    		 A total of 383 participants were included in this study of which 382 participants received treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva
    Arm description
    		 Participants received intravenous (IV) infusions of durvalumab (Durva) 1500 mg every 4 weeks (Q4W) in combination with monalizumab (Mona) 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg every 4 weeks (Q4W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva
    Arm description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva
    Arm description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva
    Arm description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva
    Arm description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC)
    Arm description
    		 Participants with microsatellite-stable colorectal cancer (MSS-CRC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian)
    Arm description
    		 Participants with ovarian cancer received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS)
    Arm description
    		 Participants with endometrial MSS received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC)
    Arm description
    		 Participants with non-small cell lung cancer (NSCLC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva
    Arm description
    		 Participants with first-line (1L) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus mFOLFOX (oxaliplatin 85 mg/m^2 IV infusion, folinic acid 400 mg/m^2 infusion, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of bevacizumab (Beva) 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of bevacizumab 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    mFOLFOX6
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of mFOLFOX (oxaliplatin 85 mg/m^2 IV infusion, folinic acid 400 mg/m^2 infusion, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Arm description
    		 Participants with 1L MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 (oxaliplatin 85 mg/m^2, folinic acid 400 mg/m^2, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of cetuximab (Cetu) (loading dose of 400 mg/m^2 on Day 1, followed by maintenance dose of 250 mg/m^2 IV infusion every week starting on Day 8, then changed to 500 mg/m^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of cetuximab (loading dose of 400 mg/m^2 on Day 1, followed by maintenance dose of 250 mg/m^2 IV infusion every week starting on Day 8, then changed to 500 mg/m^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    mFOLFOX6
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of mFOLFOX (oxaliplatin 85 mg/m^2 IV infusion, folinic acid 400 mg/m^2 infusion, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu
    Arm description
    		 Participants with recurrent or metastatic third-line (3L) RAS mutant MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Exploration Cohort C1B: Mona 750 mg Q2W + Cetu
    Arm description
    		 Participants with recurrent or metastatic 3L RAS mutant MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu
    Arm description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of durvalumab 1500 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Arm title
    		 Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Arm description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Investigational medicinal product name
    Monalizumab
    Investigational medicinal product code
    IPH2201
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Number of subjects in period 1
    		Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Started
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    40
    41
    44
    37
    Treated
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    39
    41
    44
    37
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    40
    41
    44
    37
         Adverse event, serious fatal
    -
    -
    -
    1
    -
    -
    -
    2
    1
    -
    -
    -
    -
    -
    1
         Consent withdrawn by subject
    2
    -
    2
    2
    2
    7
    2
    7
    1
    1
    2
    4
    4
    4
    2
         Death
    1
    3
    -
    15
    14
    29
    34
    26
    18
    10
    8
    29
    29
    29
    26
         Un-specified
    -
    -
    -
    -
    1
    3
    2
    3
    -
    5
    8
    4
    5
    9
    8
         Lost to follow-up
    -
    -
    1
    -
    1
    1
    2
    2
    -
    2
    -
    3
    3
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva
    Reporting group description
    		 Participants received intravenous (IV) infusions of durvalumab (Durva) 1500 mg every 4 weeks (Q4W) in combination with monalizumab (Mona) 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC)
    Reporting group description
    		 Participants with microsatellite-stable colorectal cancer (MSS-CRC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian)
    Reporting group description
    		 Participants with ovarian cancer received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS)
    Reporting group description
    		 Participants with endometrial MSS received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC)
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva
    Reporting group description
    		 Participants with first-line (1L) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus mFOLFOX (oxaliplatin 85 mg/m^2 IV infusion, folinic acid 400 mg/m^2 infusion, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of bevacizumab (Beva) 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Reporting group description
    		 Participants with 1L MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 (oxaliplatin 85 mg/m^2, folinic acid 400 mg/m^2, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of cetuximab (Cetu) (loading dose of 400 mg/m^2 on Day 1, followed by maintenance dose of 250 mg/m^2 IV infusion every week starting on Day 8, then changed to 500 mg/m^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic third-line (3L) RAS mutant MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C1B: Mona 750 mg Q2W + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS mutant MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu Total
    Number of subjects
    		 3 3 3 18 18 40 40 40 20 18 18 40 41 44 37 383
    Age Categorical
    Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    Units: Participants
        <=18 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Between 18 and 65 years
    		 1 2 2 14 10 33 24 21 9 10 15 31 36 33 27 268
        >=65 years
    		 2 1 1 4 8 7 16 19 11 8 3 9 5 11 10 115
    Age continuous
    The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    Units: years
        arithmetic mean (standard deviation)
    		 58.0 ( 21.7 ) 55.7 ( 18.0 ) 59 ( 15.1 ) 56.4 ( 13.5 ) 60 ( 13.5 ) 53.6 ( 12.9 ) 61.5 ( 9.1 ) 63.7 ( 8.1 ) 63.2 ( 7.9 ) 60.8 ( 9.9 ) 55.4 ( 9.4 ) 55.8 ( 10.7 ) 52.3 ( 10.6 ) 55.9 ( 11.3 ) 58.8 ( 9.6 ) -
    Sex: Female, Male
    The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    Units: Participants
        Female
    		 3 3 2 17 6 15 40 40 6 8 8 17 16 17 18 216
        Male
    		 0 0 1 1 12 25 0 0 14 10 10 23 25 27 19 167
    Race (NIH/OMB)
    The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1
        Asian
    		 0 0 0 1 2 3 1 2 0 1 4 9 8 14 13 58
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 1 0 0 0 0 1 0 0 0 0 1 0 3
        Black or African American
    		 0 0 0 1 0 1 3 4 1 2 0 2 1 1 1 17
        White
    		 3 3 3 15 15 36 35 30 16 13 13 29 30 25 22 288
        More than one race
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
        Unknown or Not Reported
    		 0 0 0 0 1 0 1 3 2 2 1 0 2 2 1 15
    Ethnicity (NIH/OMB)
    The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    Units: Subjects
        Hispanic or Latino
    		 1 1 0 3 0 6 5 3 2 1 1 3 6 4 0 36
        Not Hispanic or Latino
    		 2 2 3 15 17 34 35 37 16 17 17 37 35 40 37 344
        Unknown or Not Reported
    		 0 0 0 0 1 0 0 0 2 0 0 0 0 0 0 3

    End points

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    End points reporting groups
    Reporting group title
    Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva
    Reporting group description
    		 Participants received intravenous (IV) infusions of durvalumab (Durva) 1500 mg every 4 weeks (Q4W) in combination with monalizumab (Mona) 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC)
    Reporting group description
    		 Participants with microsatellite-stable colorectal cancer (MSS-CRC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian)
    Reporting group description
    		 Participants with ovarian cancer received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS)
    Reporting group description
    		 Participants with endometrial MSS received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC)
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva
    Reporting group description
    		 Participants with first-line (1L) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus mFOLFOX (oxaliplatin 85 mg/m^2 IV infusion, folinic acid 400 mg/m^2 infusion, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of bevacizumab (Beva) 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Reporting group description
    		 Participants with 1L MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 (oxaliplatin 85 mg/m^2, folinic acid 400 mg/m^2, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of cetuximab (Cetu) (loading dose of 400 mg/m^2 on Day 1, followed by maintenance dose of 250 mg/m^2 IV infusion every week starting on Day 8, then changed to 500 mg/m^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic third-line (3L) RAS mutant MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C1B: Mona 750 mg Q2W + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS mutant MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Subject analysis set title
    Dose-escalation Cohort4+Dose-expansion: Mona 750mg Q2W + Durva
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants with solid tumors, microsatellite-stable colorectal cancer (MSS-CRC), ovarian cancer, MSS endometrial cancer or non-small cell lung cancer (NSCLC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Subject analysis set title
    Dose-escalation (1-5) + dose-expansion + dose-exploration
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in dose-escalation cohorts received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 22.5, 75, 225 or 750 mg Q2W (Cohorts 1, 2, 3 and 4) or 750 mg Q4W (Cohort 5), dose-expansion cohorts participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W. Participants with recurrent or metastatic 3L RAS mutant (C1A) or RAS/BRAF wild type (C2A) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab. Participants with 1L MSS-CRC in Cohorts A1 and A2 received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 Q2W plus either IV infusion of bevacizumab 5 mg/kg Q2W (Cohort A1) or IV infusion of cetuximab (Cohort A2). Participants in all cohorts received treatment up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Subject analysis set title
    Exploration Cohorts A2, C1A, C2A, C1B, and C2B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants with recurrent or metastatic 3L RAS mutant (C1A) or RAS/BRAF wild type (C2A) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15. Participants with recurrent or metastatic 3L RAS mutant (C1B) or RAS/BRAF wild type (C2B) MSS-CRC received IV infusions monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15. Participants with 1L MSS-CRC in Cohort A2 received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 Q2W plus IV infusion of cetuximab (Cohort A2). Participants in all cohorts received treatment up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Any TEAEs data is inclusive of both serious and other adverse events (non-serious).
    End point type
    Primary
    End point timeframe
    Day 1 through 246.9 weeks (maximum observed duration)
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    39
    41
    44
    37
    Units: Participants
        Any TEAEs
    3
    3
    3
    18
    17
    39
    40
    39
    20
    18
    18
    39
    41
    44
    36
        Any TESAEs
    1
    0
    1
    8
    4
    11
    16
    17
    7
    10
    11
    10
    5
    9
    11
    No statistical analyses for this end point

    Primary: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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    End point title
    		 Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [2]
    End point description
    Change from baseline in SBP and DBP (minimum post baseline change [PBC] and maximum PBC) are reported. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) through 246.9 weeks (maximum observed duration)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    39
    41
    44
    37
    Units: mmHg
    arithmetic mean (standard deviation)
        SBP min PBC
    -19.00 ( 21.63 )
    -26.00 ( 10.82 )
    -14.67 ( 11.55 )
    -22.94 ( 12.73 )
    -23.06 ( 20.48 )
    -21.45 ( 12.89 )
    -22.55 ( 13.35 )
    -21.23 ( 12.29 )
    -26.40 ( 12.75 )
    -29.28 ( 19.19 )
    -24.61 ( 10.92 )
    -23.31 ( 12.88 )
    -20.80 ( 11.87 )
    -25.57 ( 13.99 )
    -25.05 ( 16.86 )
        SBP max PBC
    27.33 ( 5.69 )
    19.00 ( 5.57 )
    28.67 ( 20.82 )
    29.22 ( 15.78 )
    22.00 ( 19.16 )
    21.10 ( 12.04 )
    22.15 ( 17.39 )
    23.55 ( 14.13 )
    22.95 ( 11.69 )
    27.17 ( 21.63 )
    23.61 ( 11.27 )
    20.74 ( 15.31 )
    17.20 ( 10.51 )
    23.00 ( 13.18 )
    22.59 ( 15.69 )
        DBP min PBC
    -15.67 ( 18.01 )
    -22.00 ( 10.00 )
    -10.67 ( 9.07 )
    -17.89 ( 9.58 )
    -18.61 ( 11.05 )
    -16.60 ( 10.40 )
    -17.60 ( 9.81 )
    -13.05 ( 7.21 )
    -19.15 ( 10.28 )
    -18.11 ( 8.98 )
    -20.50 ( 9.79 )
    -16.13 ( 9.33 )
    -16.39 ( 9.94 )
    -18.09 ( 9.69 )
    -17.68 ( 12.15 )
        DBP max PBC
    23.67 ( 11.93 )
    11.67 ( 4.93 )
    18.00 ( 9.64 )
    14.06 ( 12.75 )
    12.39 ( 9.30 )
    15.58 ( 9.69 )
    12.63 ( 11.11 )
    19.83 ( 10.15 )
    16.65 ( 9.46 )
    18.11 ( 9.33 )
    14.22 ( 12.18 )
    13.54 ( 10.01 )
    13.10 ( 8.98 )
    16.05 ( 10.06 )
    14.43 ( 9.01 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Respiratory Rate (RR)

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    End point title
    		 Change From Baseline in Respiratory Rate (RR) [3]
    End point description
    Change from baseline in RR (minimum PBC and maximum PBC) are reported. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) through 246.9 weeks (maximum observed duration)
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    39
    41
    44
    37
    Units: breaths/min
    arithmetic mean (standard deviation)
        RR min PBC
    -2.00 ( 2.00 )
    -3.00 ( 1.00 )
    -1.33 ( 2.31 )
    -1.78 ( 1.31 )
    -1.50 ( 1.86 )
    -1.93 ( 1.86 )
    -1.53 ( 1.52 )
    -1.83 ( 1.62 )
    -1.55 ( 3.12 )
    -2.00 ( 1.94 )
    -1.67 ( 1.78 )
    -2.15 ( 2.23 )
    -1.59 ( 1.52 )
    -2.00 ( 1.33 )
    -1.92 ( 1.89 )
        RR max PBC
    2.00 ( 3.46 )
    2.33 ( 0.58 )
    2.67 ( 1.15 )
    1.72 ( 1.49 )
    1.83 ( 1.42 )
    2.40 ( 2.37 )
    2.53 ( 2.24 )
    2.40 ( 2.62 )
    4.05 ( 3.09 )
    2.50 ( 2.09 )
    3.39 ( 3.62 )
    1.85 ( 1.73 )
    2.00 ( 1.55 )
    2.59 ( 1.83 )
    3.14 ( 4.60 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Pulse Rate (PR)

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    End point title
    		 Change From Baseline in Pulse Rate (PR) [4]
    End point description
    Change from baseline in PR (minimum PBC and maximum PBC) are reported. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) through 246.9 weeks (maximum observed duration)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    38
    40
    20
    18
    18
    39
    41
    44
    37
    Units: beats/min
    arithmetic mean (standard deviation)
        PR min PBC
    -5.33 ( 2.52 )
    -14.33 ( 6.51 )
    -7.00 ( 1.73 )
    -15.67 ( 11.83 )
    -15.39 ( 9.20 )
    -14.70 ( 9.39 )
    -12.24 ( 10.10 )
    -11.38 ( 10.98 )
    -13.95 ( 9.12 )
    -15.67 ( 8.84 )
    -18.11 ( 11.98 )
    -15.74 ( 11.20 )
    -13.15 ( 11.89 )
    -13.91 ( 7.04 )
    -11.68 ( 9.02 )
        PR max PBC
    38.33 ( 10.02 )
    16.67 ( 6.11 )
    21.67 ( 8.08 )
    19.33 ( 15.05 )
    17.78 ( 11.12 )
    20.28 ( 10.03 )
    20.68 ( 13.42 )
    22.60 ( 12.17 )
    25.80 ( 11.27 )
    21.28 ( 13.48 )
    21.06 ( 12.24 )
    23.54 ( 12.83 )
    23.88 ( 11.31 )
    25.18 ( 13.71 )
    27.38 ( 13.92 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Body Temperature (BT)

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    End point title
    		 Change From Baseline in Body Temperature (BT) [5]
    End point description
    Change from baseline in BT (minimum PBC and maximum PBC) are reported. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) through 246.9 weeks (maximum observed duration)
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    39
    41
    44
    37
    Units: degree Celsius
    arithmetic mean (standard deviation)
        BT min PBC
    -0.30 ( 0.30 )
    -0.37 ( 0.38 )
    -0.67 ( 0.55 )
    -0.66 ( 0.56 )
    -0.48 ( 0.28 )
    -0.62 ( 0.39 )
    -0.63 ( 0.42 )
    -0.47 ( 0.32 )
    -0.51 ( 0.26 )
    -0.84 ( 0.46 )
    -0.79 ( 0.48 )
    -0.51 ( 0.39 )
    -0.52 ( 0.33 )
    -0.65 ( 0.45 )
    -0.66 ( 0.58 )
        BT max PBC
    0.63 ( 0.32 )
    0.93 ( 0.92 )
    0.50 ( 0.26 )
    0.78 ( 0.72 )
    0.60 ( 0.73 )
    0.65 ( 0.43 )
    0.64 ( 0.46 )
    0.77 ( 0.47 )
    0.72 ( 0.46 )
    0.89 ( 0.51 )
    0.56 ( 0.43 )
    0.75 ( 0.57 )
    0.70 ( 0.53 )
    0.91 ( 0.64 )
    0.81 ( 0.66 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Oxygen Saturation (OS)

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    End point title
    		 Change From Baseline in Oxygen Saturation (OS) [6]
    End point description
    Change from baseline in OS (minimum PBC and maximum PBC) are reported. The arbitrary number 99999 signified standard deviation was not reported as only one participant was evaluable for the specified arm group. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) through 246.9 weeks (maximum observed duration)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    1
    0 [7]
    0 [8]
    1
    1
    3
    1
    0 [9]
    1
    2
    1
    0 [10]
    2
    1
    6
    Units: Percentage of oxygen saturation
    arithmetic mean (standard deviation)
        OS min PBC
    -1.00 ( 99999 )
    ( )
    ( )
    -3.00 ( 99999 )
    -3.00 ( 99999 )
    -0.67 ( 1.53 )
    -21.00 ( 99999 )
    ( )
    0 ( 99999 )
    0.50 ( 2.12 )
    -4.00 ( 99999 )
    ( )
    0.50 ( 0.71 )
    -1.00 ( 99999 )
    -0.33 ( 2.80 )
        OS max PBC
    -1.00 ( 99999 )
    ( )
    ( )
    -3.00 ( 99999 )
    -3.00 ( 99999 )
    -0.67 ( 1.53 )
    -21.00 ( 99999 )
    ( )
    0 ( 99999 )
    0.50 ( 2.12 )
    -4.00 ( 99999 )
    ( )
    0.50 ( 0.71 )
    -1.00 ( 99999 )
    -0.33 ( 2.80 )
    Notes
    [7] - No participants were analyzed for change in OS.
    [8] - No participants were analyzed for change in OS.
    [9] - No participants were analyzed for change in OS.
    [10] - No participants were analyzed for change in OS.
    No statistical analyses for this end point

    Primary: Number of Participants With Notable Change in QTcF and QTcB From Baseline

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    End point title
    		 Number of Participants With Notable Change in QTcF and QTcB From Baseline [11]
    End point description
    Participants who had notable QTcF and QTcB interval change from baseline are reported. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) through 246.9 weeks (maximum observed duration)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    16
    18
    39
    38
    40
    19
    18
    17
    39
    40
    43
    37
    Units: Participants
        QTcF>30 msec
    0
    0
    0
    2
    1
    6
    5
    2
    2
    1
    2
    3
    3
    5
    5
        QTcF>60 msec
    0
    0
    0
    1
    0
    0
    2
    1
    1
    0
    0
    1
    1
    0
    1
        QTcB>30 msec
    1
    0
    0
    3
    2
    5
    5
    4
    3
    1
    6
    4
    8
    9
    6
        QTcB>60 msec
    0
    0
    0
    1
    0
    1
    3
    1
    1
    0
    0
    1
    2
    0
    1
    No statistical analyses for this end point

    Primary: Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters

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    End point title
    		 Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters [12]
    End point description
    Number of participants with at least 2-Grade shift from baseline in laboratory parameters are reported. Laboratory parameters included anaemia (AA), white blood cell decreased (WBCD), lymphocyte count decreased (LCD), lymphocyte count increased (LCI), neutrophil count decreased (NCD), platelet count decreased (PCD), hypoalbuminemia (HA),creatinine increased (CI), gamma glutamyl transferase increased (GGTI), hyponatremia (HN), hyperglycemia (HG), serum amylase increased (SAI), aspartate aminotransferase (AST) increased, blood bilirubin increased (BBI), lipase increased (LI), and hypertriglyceridemia (HTG). As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number analyzed (n) denotes, number of participants analyzed for the specified laboratory parameter.
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) through 246.9 weeks (maximum observed duration)
    Notes
    [12] - 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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    39
    41
    44
    37
    Units: Participants
        AA (n=3,3,3,17,18,40,38,38,20,17,18,39,41,44,37)
    0
    0
    1
    2
    1
    2
    1
    2
    0
    1
    2
    2
    2
    0
    2
        WBCD (n=3,3,3,17,18,40,38,38,20,17,18,39,41,44,37)
    0
    0
    0
    0
    0
    1
    1
    2
    0
    7
    6
    0
    2
    4
    1
        LCD (n=3,3,3,17,18,40,38,38,20,17,18,39,41,44,37)
    0
    1
    1
    4
    4
    5
    7
    8
    5
    5
    4
    6
    3
    7
    8
        LCI (n=0,0,0,0,0,0,0,0,0,17,18,39,41,44,37)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
        NCD (n=3,3,3,17,18,40,38,38,20,17,18,37,37,36,31)
    0
    0
    0
    0
    0
    1
    2
    1
    0
    9
    11
    0
    1
    1
    1
        PCD (n=3,3,3,17,18,40,38,38,20,17,18,39,41,43,37)
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    2
    1
    0
    0
    3
        HA (n=3,3,3,18,18,40,40,40,20,18,18,39,41,44,36)
    1
    0
    0
    6
    3
    6
    6
    6
    2
    2
    2
    9
    2
    6
    5
        CI (n=3,3,3,18,18,40,40,40,20,18,18,0,0,0,0)
    1
    1
    1
    1
    4
    4
    4
    8
    2
    4
    2
    0
    0
    0
    0
        GGTI (n=3,3,3,18,18,0,0,0,0,0,0,0,0,0,0)
    0
    0
    0
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        HN (n=3,3,3,18,18,40,40,40,20,18,18,0,0,0,0)
    1
    0
    1
    2
    3
    3
    5
    5
    1
    4
    2
    0
    0
    0
    0
        HG (n=0,0,0,0,0,40,40,40,20,18,18,0,0,0,0)
    0
    0
    0
    0
    0
    3
    4
    3
    5
    1
    5
    0
    0
    0
    0
        SAI (n=0,0,0,0,0,0,0,0,0,18,18,0,0,0,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    6
    0
    0
    0
    0
        ASTI (n=0,0,0,0,0,0,0,0,0,18,18,0,0,0,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
        BBI (n=0,0,0,0,0,0,0,0,0,18,18,39,40,43,37)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    2
    7
    7
    3
    6
        LI (n=0,0,0,0,0,0,0,0,0,18,18,39,40,44,36)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    10
    5
    6
    7
    5
        HTG (n=0,0,0,0,0,0,0,0,0,18,18,0,0,0,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    3
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Dose Limiting Toxicities (DLTs)

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    End point title
    		 Number of Participants With Dose Limiting Toxicities (DLTs) [13] [14]
    End point description
    DLT:Any study drug related Grade (G) 3 or higher toxicity that occurred during DLT evaluation period including: any G>=3 noninfectious colitis/pneumonitis, liver transaminase elevation (TE) >=5 but =<8 upper limit of normal (ULN), any G4 immune-mediated AE (imAE)/immune-related AE (irAE), any G>=3 clinically significant non-hematologic toxicity, TE >8 ULN or total bilirubin (TBL) >5 ULN, increase in AST or ALT >=3 ULN along with TBL >=2 ULN, thrombocytopenia (G3/4 associated with G3/higher hemorrhage, G3 that did not improve by at least 1 grade within 7 days, and G4), G4 febrile neutropenia (FN), G3 FN of >=5 days and G3 FN regardless of duration, G4 neutropenia of >7 days, G3/4 neutropenia not associated with fever/systemic infection, and anemia (G3 and G4). DLT-Evaluable (DLTE) population included all participants enrolled in dose-escalation part who received at least 1 dose of study drugs and completed safety follow-up through DLTE period or experienced any DLT during DLTE period.
    End point type
    Primary
    End point timeframe
    From Day 1 to 28 days after the first dose of study drugs
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    [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: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva
    Number of subjects analysed
    3
    3
    3
    17
    18
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B

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    End point title
    		 Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B [15] [16]
    End point description
    The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST V 1.1) guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    End point type
    Primary
    End point timeframe
    Baseline (Days -28 to -1) through 54.8 months (maximum observed duration)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    40
    41
    Units: Percentage of Participants
        number (confidence interval 95%)
    0 (0.0 to 10.3)
    0 (0.0 to 9.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With OR

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    End point title
    		 Percentage of Participants With OR [17]
    End point description
    The OR is defined as best overall response of CR or confirmed PR according to RECIST V 1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Baseline (Days -28 to -1) through 54.8 months (maximum observed duration)
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    Units: Percentage of Participants
        number (confidence interval 95%)
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
    0 (0.0 to 84.2)
    0 (0.0 to 19.5)
    0 (0.0 to 19.5)
    7.5 (1.6 to 20.4)
    5.0 (0.7 to 18.2)
    0 (0.0 to 9.5)
    10.0 (1.2 to 31.7)
    44.4 (23.0 to 72.2)
    72.2 (46.5 to 90.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Disease Control (DC)

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    End point title
    		 Percentage of Participants with Disease Control (DC) [18]
    End point description
    The DC is defined as best overall response of confirmed CR, confirmed PR, or stable disease (SD) based on RECIST v1.1. The CR is defined as disappearance of all target, non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants with SD were included in the DC if they maintained SD for >= 8 weeks from start of treatment. The DCR16 and DCR24 are reported (participants with SD >= 16 weeks and >=24 weeks). As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    Units: Percentage of Participants
    number (confidence interval 95%)
        DCR16
    0 (0.0 to 70.8)
    33.3 (0.8 to 90.6)
    0 (0.0 to 70.8)
    22.2 (6.4 to 47.6)
    27.8 (9.7 to 53.5)
    30 (16.6 to 46.5)
    30 (16.6 to 46.5)
    25 (12.7 to 41.2)
    40 (19.1 to 63.9)
    77.8 (52.4 to 93.6)
    88.9 (65.3 to 98.6)
        DCR24
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
    0 (0.0 to 18.5)
    11.1 (1.4 to 34.7)
    17.5 (7.3 to 32.8)
    15 (5.7 to 29.8)
    12.5 (4.2 to 26.8)
    25 (8.7 to 49.1)
    66.7 (41.0 to 86.7)
    77.8 (52.4 to 93.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With OR in Exploration Cohorts C2A and C2B

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    End point title
    		 Percentage of Participants With OR in Exploration Cohorts C2A and C2B [19]
    End point description
    The OR is defined as best overall response of confirmed CR or confirmed PR according to RECIST V 1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    44
    37
    Units: Percentage of Participants
        number (confidence interval 95%)
    11.4 (4.0 to 25.6)
    5.4 (0.7 to 18.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with DC in Exploration Cohorts (C1A, C1B, C2A, and C2B)

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    End point title
    		 Percentage of Participants with DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) [20]
    End point description
    The DC is defined as best overall response of confirmed CR, confirmed PR, or SD based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Participants with SD were included in the DC if they maintained SD for >= 8 weeks from start of treatment. The DCR16 and DCR24 are reported (participants with SD >= 16 weeks and >=24 weeks). The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    40
    41
    44
    37
    Units: Percentage of Participants
    number (confidence interval 95%)
        DCR16
    17.5 (7.3 to 32.8)
    34.1 (20.1 to 50.6)
    59.1 (43.2 to 73.7)
    56.8 (39.5 to 72.9)
        DCR24
    10.0 (2.8 to 23.7)
    7.3 (1.5 to 19.9)
    52.3 (36.7 to 67.5)
    45.9 (29.5 to 63.1)
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR) [21]
    End point description
    The DoR is defined as the duration from the first documentation of OR (confirmed 2 CRs [disappearance of all target, non-target lesions and normalization of tumor marker level lesions] or confirmed 2 PRs [>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion]) to the first documented PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. The DoR was evaluated using Kaplan-Meier method. The arbitrary number 99999 signified upper limit confidence interval (CI) could not be derived due to insufficient events being observed. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Participants who had achieved OR were evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    3
    2
    0 [27]
    2
    8
    13
    Units: Weeks
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    16.1 (15.9 to 99999)
    68.1 (24.0 to 99999)
    ( to )
    22.9 (10.1 to 99999)
    66.1 (16.1 to 85.4)
    72.3 (17.4 to 99999)
    Notes
    [22] - No participant has achieved OR in this treatment arm group.
    [23] - No participant has achieved OR in this treatment arm group.
    [24] - No participant has achieved OR in this treatment arm group.
    [25] - No participant has achieved OR in this treatment arm group.
    [26] - No participant has achieved OR in this treatment arm group.
    [27] - No participant has achieved OR in this treatment arm group.
    No statistical analyses for this end point

    Secondary: DoR in Exploration Cohorts (C1A, C1B, C2A, and C2B)

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    End point title
    		 DoR in Exploration Cohorts (C1A, C1B, C2A, and C2B) [28]
    End point description
    The DoR is defined as the duration from the first documentation of OR (confirmed 2 CRs [disappearance of all target, non-target lesions and normalization of tumor marker level lesions] or confirmed 2 PRs [(>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion]) to the first documented PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. The DoR was evaluated using Kaplan-Meier method. The arbitrary number 99999 signified upper limit CI could not be derived due to insufficient events being observed. The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to. Participants who had achieved OR were evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    0 [29]
    0 [30]
    5
    2
    Units: Weeks
        median (confidence interval 95%)
    ( to )
    ( to )
    32.1 (16.0 to 99999)
    24.1 (12.1 to 99999)
    Notes
    [29] - No participant has achieved OR in this treatment arm group.
    [30] - No participant has achieved OR in this treatment arm group.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS) [31]
    End point description
    The PFS is defined as the time from the start of study treatment until the first documentation of PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The arbitrary numbers 0.99999 and 99999 signified the data for lower and upper limit of CI could not be derived due to insufficient events being observed. The PFS was estimated using Kaplan-Meier method. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    Units: Months
        median (confidence interval 95%)
    1.8 (1.7 to 99999)
    1.9 (1.8 to 99999)
    1.9 (0.99999 to 99999)
    2.0 (1.7 to 3.4)
    1.8 (1.7 to 3.5)
    1.9 (1.8 to 3.6)
    1.8 (1.7 to 1.9)
    1.8 (1.7 to 3.3)
    1.9 (1.7 to 3.7)
    10.9 (5.7 to 17.7)
    14.7 (5.8 to 20.9)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B)

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    End point title
    		 Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B) [32]
    End point description
    The PFS is defined as the time from the start of study treatment until the first documentation of PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method. The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    40
    41
    44
    37
    Units: Months
        median (confidence interval 95%)
    1.8 (1.7 to 1.9)
    2.0 (1.7 to 3.3)
    5.3 (3.2 to 5.5)
    4.4 (2.1 to 5.5)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival [33]
    End point description
    The overall survival is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. The arbitrary numbers 0.99999, 99999, and 99.999 signified the data for lower limit of CI, upper limit of CI, and median, respectively, could note be derived due to insufficient events being observed.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    Units: Months
        median (confidence interval 95%)
    15.1 (0.99999 to 99999)
    20.1 (18.6 to 99999)
    99.999 (0.9999 to 99999)
    8.1 (4.0 to 16.7)
    13.4 (4.4 to 16.9)
    10.6 (6.0 to 20.1)
    16.7 (10.7 to 21.4)
    11.0 (6.7 to 17.3)
    8.8 (5.8 to 15.6)
    25.6 (13.8 to 99999)
    29.6 (19.8 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B)

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    End point title
    		 Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B) [34]
    End point description
    The overall survival is defined as the time from the start of study treatment until death due to any cause. The overall survival was estimated using Kaplan-Meier method. The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
    End point type
    Secondary
    End point timeframe
    Baseline (-28 to -1 day) through 54.8 weeks (maximum observed duration)
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    40
    41
    44
    37
    Units: Months
        median (confidence interval 95%)
    10.3 (4.3 to 12.7)
    8.9 (6.8 to 11.3)
    14.6 (10.0 to 19.4)
    14.6 (7.2 to 18.7)
    No statistical analyses for this end point

    Secondary: Maximum Observed Serum Concentration (Cmax) of Monalizumab

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    End point title
    		 Maximum Observed Serum Concentration (Cmax) of Monalizumab [35]
    End point description
    Serum Cmax of monalizumab at pre-dose and end of infusion are reported. The arbitrary number 99999 signified standard deviation was not reported as only one participant was evaluable for the specified arm. Pharmacokinetic evaluable population included participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number of subjects analyzed denotes those subjects who had adequate PK sample available for analysis. Data for dose-escalation Cohort 4 and dose-expansion Cohorts (MSS-CRC, Ovarian, Endometrial MSS and NSCLC) were combined in a single arm/group to avoid increased variability due to smaller cohort sizes.
    End point type
    Secondary
    End point timeframe
    Day 85: Pre-dose and end of infusion (within 10 minutes) after cohort specific infusions
    Notes
    [35] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu Dose-escalation Cohort4+Dose-expansion: Mona 750mg Q2W + Durva
    Number of subjects analysed
    1
    2
    1
    6
    7
    9
    10
    11
    19
    19
    60
    Units: µg/mL
        arithmetic mean (standard deviation)
    7.85 ( 99999 )
    43.62 ( 12.54 )
    144.88 ( 99999 )
    245.18 ( 142.35 )
    304.48 ( 66.75 )
    281.53 ( 155.57 )
    346.85 ( 91.06 )
    388.60 ( 194.64 )
    289.25 ( 194.59 )
    409.93 ( 175.43 )
    315.74 ( 129.08 )
    No statistical analyses for this end point

    Secondary: Minimum Observed Serum Concentration (Cmin) of Monalizumab

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    End point title
    		 Minimum Observed Serum Concentration (Cmin) of Monalizumab [36]
    End point description
    Serum Cmin of monalizumab at pre-dose and end of infusion are reported. The arbitrary number 99999 signified standard deviation was not reported as only one participant was evaluable for the specified arm. Pharmacokinetic evaluable population included participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number of subjects analyzed denotes those subjects who had adequate PK sample available for analysis. Data for dose-escalation Cohort 4 and dose-expansion Cohorts (MSS-CRC, Ovarian, Endometrial MSS and NSCLC) were combined in a single arm/group to avoid increased variability due to smaller cohort sizes.
    End point type
    Secondary
    End point timeframe
    Day 85: Pre-dose and end of infusion (within 10 minutes) after cohort specific infusions
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu Dose-escalation Cohort4+Dose-expansion: Mona 750mg Q2W + Durva
    Number of subjects analysed
    1
    2
    1
    6
    10
    11
    11
    11
    22
    22
    61
    Units: µg/mL
        arithmetic mean (standard deviation)
    7.45 ( 99999 )
    18.16 ( 6.70 )
    92.55 ( 99999 )
    67.75 ( 57.82 )
    141.39 ( 57.01 )
    109.18 ( 45.54 )
    129.59 ( 45.72 )
    172.90 ( 84.55 )
    148.05 ( 70.23 )
    185.60 ( 105.68 )
    145.04 ( 76.34 )
    No statistical analyses for this end point

    Secondary: Serum Concentration of Durvalumab

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    End point title
    		 Serum Concentration of Durvalumab
    End point description
    Serum concentration of durvalumab is reported. Pharmacokinetic evaluable population included participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number analyzed (n) denotes those participants who had adequate PK sample available for analysis for specified time point. The data is combined in a single arm with a respectable sample size as values from different cohorts with small cohort size will increase variability.
    End point type
    Secondary
    End point timeframe
    Pre-dose (PRE) on Day 1 of Weeks 1, 5, 9, 13, and 25 and post-dose (POST) on Day 1 of Weeks 1 and 13
    End point values
    		 Dose-escalation (1-5) + dose-expansion + dose-exploration
    Number of subjects analysed
    287
    Units: µg/mL
    arithmetic mean (standard deviation)
        Week 1 Day 1 (PRE) (n=287)
    0.100 ( 0.63 )
        Week 1 Day 1 (POST) (n=285)
    399 ( 157 )
        Week 5 Day 1 (PRE) (n=248)
    90.8 ( 95.0 )
        Week 9 Day 1 (PRE) (n=193)
    127 ( 148 )
        Week 13 Day 1 (PRE) (n=140)
    142 ( 123 )
        Week 13 Day 1 (POST) (n=126)
    497 ( 277 )
        Week 25 Day 1 (PRE) (n=79)
    149 ( 109 )
    No statistical analyses for this end point

    Secondary: Serum Concentration of Cetuximab

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    End point title
    		 Serum Concentration of Cetuximab
    End point description
    Serum concentration of cetuximab is reported. Pharmacokinetic evaluable population included participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number analyzed (n) denotes those participants who had adequate PK sample available for analysis for specified time point. The data is combined in a single arm with a respectable sample size as values from different cohorts with small cohort size will increase variability.
    End point type
    Secondary
    End point timeframe
    Pre-dose (PRE) on Day 1 of Week 1, 5, 9, 13, and post-dose (POST) on Day 1 of Week 1, 5, and 13 at the end of infusion
    End point values
    		 Exploration Cohorts A2, C1A, C2A, C1B, and C2B
    Number of subjects analysed
    70
    Units: µg/mL
    arithmetic mean (standard deviation)
        Week 1 Day 1 (PRE) (n=54)
    0.025 ( 0.00 )
        Week 1 Day 1 (POST) (n=70)
    400 ( 138 )
        Week 5 Day 1 (PRE) (n=48)
    73.6 ( 108.0 )
        Week 5 Day 1 (POST) (n=6)
    344 ( 161 )
        Week 9 Day 1 (PRE) (n=18)
    97.7 ( 137 )
        Week 13 Day 1 (PRE) (n=19)
    61.7 ( 113 )
        Week 13 Day 1 (POST) (n=20)
    387 ( 101 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab

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    End point title
    		 Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab
    End point description
    Number of participants with positive ADA to monalizumab are reported. Persistent positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >=2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher-level following drug administration. Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of subjects analyzed denotes those participants who had post-baseline ADA results.
    End point type
    Secondary
    End point timeframe
    Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 13, and 25, and 90 days after the last dose of monalizumab)
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    15
    16
    36
    35
    32
    18
    16
    18
    30
    38
    37
    34
    Units: Participants
        Persistent Positive
    0
    0
    0
    2
    0
    10
    5
    4
    2
    0
    1
    5
    5
    3
    5
        Transient Positive
    0
    0
    0
    1
    0
    1
    2
    1
    2
    0
    0
    1
    1
    2
    0
        Treatment-boosted ADA
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Treatment-emergent ADA
    0
    0
    0
    3
    0
    11
    7
    5
    4
    0
    1
    6
    6
    5
    5
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive ADA to Durvalumab

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    End point title
    		 Number of Participants With Positive ADA to Durvalumab
    End point description
    Number of participants with positive ADA to monalizumab are reported. The persistent positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. The transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). The treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher-level following drug administration. The treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of subjects analyzed denotes those participants who had post-baseline ADA results.
    End point type
    Secondary
    End point timeframe
    Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 13, and 25, and 90 days after the last dose of monalizumab)
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    15
    9
    36
    33
    31
    18
    17
    18
    30
    2
    39
    1
    Units: Participants
        Persistent Positive
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Transient Positive
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Treatment-boosted ADA
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Treatment-emergent ADA
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive ADA to Cetuximab

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    End point title
    		 Number of Participants With Positive ADA to Cetuximab [37]
    End point description
    Number of participants with positive ADA to cetuximab are reported. The persistent positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. The transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). The treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher-level following drug administration. The treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of subjects analyzed denotes those participants who had post-baseline ADA results.
    End point type
    Secondary
    End point timeframe
    Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 9 [if EOT occurred], and 13, and 30 days after the last dose of monalizumab)
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    18
    28
    35
    1
    0 [38]
    Units: Participants
        Persistent Positive
    0
    1
    0
    0
        Transient Positive
    0
    0
    0
    0
        Treatment-boosted ADA
    0
    0
    0
    0
        Treatment-emergent ADA
    0
    1
    0
    0
    Notes
    [38] - No participant had adequate ADA sample.
    No statistical analyses for this end point

    Secondary: Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies

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    End point title
    		 Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies
    End point description
    Number of participants with PD-L1 expression in pre-treatment tumor biopsies is reported. The participants were stratified into four categories: tumor cells (TC) >= 25%, TC<25%, TC>=1%, and TC<1%, based on the historical use of PD-L1 cutoffs. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of subjects analyzed denotes those participants for whom PD-L1 testing was performed, and for whom PD-L1 status was obtained.
    End point type
    Secondary
    End point timeframe
    Screening (Days -28 to -1)
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    13
    14
    29
    37
    32
    16
    16
    18
    31
    33
    36
    32
    Units: Participants
        TC>=25%
    0
    0
    0
    2
    1
    0
    5
    1
    6
    0
    0
    0
    1
    1
    0
        TC<25%
    3
    3
    3
    11
    13
    29
    32
    31
    10
    16
    18
    31
    32
    35
    32
        TC>=1%
    1
    1
    1
    6
    2
    5
    22
    16
    8
    3
    0
    5
    7
    7
    5
        TC<1%
    2
    2
    2
    7
    12
    24
    15
    16
    8
    13
    18
    26
    26
    29
    27
    No statistical analyses for this end point

    Secondary: Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies

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    End point title
    		 Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies
    End point description
    The HLA-E expression in pre-treatment tumor biopsies is reported. As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Screening (Days -28 to -1)
    End point values
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Exploration Cohort A1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Number of subjects analysed
    3
    3
    3
    18
    18
    40
    40
    40
    20
    18
    18
    39
    41
    44
    37
    Units: Participants
        HLA-E Carcinoma
    3
    3
    3
    12
    13
    28
    36
    32
    16
    16
    17
    30
    33
    34
    32
        HLA-E Lymphocyte
    3
    3
    3
    12
    13
    30
    37
    32
    17
    16
    17
    29
    32
    34
    32
        HLA-E Endothelium
    3
    3
    3
    13
    13
    30
    37
    33
    17
    16
    17
    30
    31
    34
    32
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through 246.9 weeks (maximum observed duration)
    Adverse event reporting additional description
    Total number of death data was analysed as per ITT population, and AE/SAE data was analysed as per As-treated population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva
    Reporting group description
    		 Participants received intravenous (IV) infusions of durvalumab 1500 mg every 4 weeks (Q4W) in combination with monalizumab 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu
    Reporting group description
    		 Participants with 1L MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 (oxaliplatin 85 mg/m^2, folinic acid 400 mg/m^2, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of cetuximab (loading dose of 400 mg/m^2 on Day 1, followed by maintenance dose of 250 mg/m^2 IV infusion every week starting on Day 8, then changed to 500 mg/m^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration CohortA1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva
    Reporting group description
    		 Participants with first-line (1L) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus mFOLFOX (oxaliplatin 85 mg/m^2 IV infusion, folinic acid 400 mg/m^2 infusion, fluorouracil 400 mg/m^2 IV bolus, followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of bevacizumab 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC)
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva
    Reporting group description
    		 Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC)
    Reporting group description
    		 Participants with microsatellite-stable colorectal cancer (MSS-CRC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian)
    Reporting group description
    		 Participants with ovarian cancer received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS)
    Reporting group description
    		 Participants with endometrial MSS received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C1B: Mona 750 mg Q2W + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS mutant MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic third-line (3L) RAS mutant MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Reporting group title
    Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Reporting group description
    		 Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m^2 on Day 1 then 500 mg/m^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

    Serious adverse events
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration CohortA1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    11 / 18 (61.11%)
    10 / 18 (55.56%)
    7 / 20 (35.00%)
    1 / 3 (33.33%)
    8 / 18 (44.44%)
    4 / 18 (22.22%)
    11 / 40 (27.50%)
    16 / 40 (40.00%)
    17 / 40 (42.50%)
    9 / 44 (20.45%)
    5 / 41 (12.20%)
    10 / 40 (25.00%)
    11 / 37 (29.73%)
         number of deaths (all causes)
    1
    3
    8
    10
    19
    0
    16
    14
    29
    34
    28
    29
    29
    29
    27
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed [1]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed [2]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Embolism
         subjects affected / exposed [3]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Lymphoedema
         subjects affected / exposed [4]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [5]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed [6]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Pelvic venous thrombosis
         subjects affected / exposed [7]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Fatigue
         subjects affected / exposed [8]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed [9]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [10]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [11]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed [12]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [13]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed [14]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [15]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    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
    Systemic inflammatory response syndrome
         subjects affected / exposed [16]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed [17]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Intermenstrual bleeding
         subjects affected / exposed [18]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 failure
         subjects affected / exposed [19]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [20]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [21]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [22]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [23]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed [24]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed [25]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed [26]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed [27]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed [28]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related 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
    Investigations
    Transaminases increased
         subjects affected / exposed [29]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed [30]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Lower limb fracture
         subjects affected / exposed [31]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [32]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed [33]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 complication
         subjects affected / exposed [34]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed [35]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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 [36]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Atrial flutter
         subjects affected / exposed [37]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed [38]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Myocardial ischaemia
         subjects affected / exposed [39]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed [40]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Encephalitis autoimmune
         subjects affected / exposed [41]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed [42]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed [43]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed [44]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed [45]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Transient ischaemic attack
         subjects affected / exposed [46]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed [47]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed [48]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed [49]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed [50]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed [51]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [52]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    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
    Colitis
         subjects affected / exposed [53]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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 / 2
    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
    Colonic fistula
         subjects affected / exposed [54]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [55]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Diarrhoea
         subjects affected / exposed [56]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed [57]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 fistula
         subjects affected / exposed [58]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [59]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [60]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Haematochezia
         subjects affected / exposed [61]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [62]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed [63]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Large intestinal stenosis
         subjects affected / exposed [64]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Large intestinal obstruction
         subjects affected / exposed [65]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Pancreatitis
         subjects affected / exposed [66]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [67]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed [68]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 haemorrhage
         subjects affected / exposed [69]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [70]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 3
    0 / 1
    0 / 1
    0 / 2
    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
    Vomiting
         subjects affected / exposed [71]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed [72]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed [73]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed [74]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [75]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    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
    Haematuria
         subjects affected / exposed [76]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed [77]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed [78]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcapsular renal haematoma
         subjects affected / exposed [79]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 obstruction
         subjects affected / exposed [80]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed [81]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [82]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Biliary sepsis
         subjects affected / exposed [83]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed [84]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed [85]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed [86]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalomyelitis
         subjects affected / exposed [87]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [88]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed [89]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed [90]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed [91]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Metapneumovirus infection
         subjects affected / exposed [92]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [93]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [94]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed [95]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 tract infection
         subjects affected / exposed [96]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 [97]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Upper respiratory tract infection
         subjects affected / exposed [98]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Urinary tract infection
         subjects affected / exposed [99]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 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
    Urosepsis
         subjects affected / exposed [100]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed [101]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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 / 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
    Decreased appetite
         subjects affected / exposed [102]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed [103]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed [104]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed [105]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed [106]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Hypocalcaemia
         subjects affected / exposed [107]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed [108]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed [109]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed [110]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [51] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [52] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [53] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [54] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [55] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [56] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [57] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [58] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [59] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [60] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [61] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [62] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [63] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [64] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [65] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [66] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [67] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [68] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [69] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [70] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [71] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [72] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [73] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [74] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [75] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [76] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [77] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [78] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [79] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [80] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [81] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [82] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [83] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [84] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [85] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [86] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [87] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [88] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [89] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [90] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [91] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [92] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [93] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [94] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [95] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [96] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [97] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [98] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [99] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [100] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [101] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [102] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [103] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [104] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [105] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [106] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [107] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [108] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [109] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [110] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dose-escalation Cohort 1: Mona 22.5 mg Q2W + Durva Dose-escalation Cohort 2: Mona 75 mg Q2W + Durva Exploration CohortA2: Mona 750 mg Q2W+Durva+mFOLFOX6+Cetu Exploration CohortA1: Mona 750 mg Q2W+Durva + mFOLFOX6 + Beva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (NSCLC) Dose-escalation Cohort 3: Mona 225 mg Q2W + Durva Dose-escalation Cohort 4: Mona 750 mg Q2W + Durva Dose-escalation Cohort 5: Mona 750 mg Q4W + Durva Dose-expansion Cohort: Mona 750 mg Q2W + Durva (MSS-CRC) Dose-expansion Cohort: Mona 750 mg Q2W + Durva (ovarian) Dose-expansion Cohort: Mona 750 mg Q2W+Durva (Endometrial MSS) Exploration Cohort C2A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C1B: Mona 750 mg Q2W + Cetu Exploration Cohort C1A: Mona 750 mg Q2W + Durva + Cetu Exploration Cohort C2B: Mona 750 mg Q2W + Cetu
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    18 / 18 (100.00%)
    18 / 18 (100.00%)
    20 / 20 (100.00%)
    3 / 3 (100.00%)
    18 / 18 (100.00%)
    16 / 18 (88.89%)
    39 / 40 (97.50%)
    40 / 40 (100.00%)
    39 / 40 (97.50%)
    44 / 44 (100.00%)
    41 / 41 (100.00%)
    39 / 40 (97.50%)
    36 / 37 (97.30%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant ascites
         subjects affected / exposed [111]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Basal cell carcinoma
         subjects affected / exposed [112]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Cancer pain
         subjects affected / exposed [113]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    2
    1
    0
    0
    0
    Squamous cell carcinoma
         subjects affected / exposed [114]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Tumour associated fever
         subjects affected / exposed [115]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Tumour pain
         subjects affected / exposed [116]
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    1
    0
    Vascular disorders
    Embolism
         subjects affected / exposed [117]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Deep vein thrombosis
         subjects affected / exposed [118]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    2
    0
    1
    0
    1
    Flushing
         subjects affected / exposed [119]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Haematoma
         subjects affected / exposed [120]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Jugular vein thrombosis
         subjects affected / exposed [121]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hypertension
         subjects affected / exposed [122]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    4 / 18 (22.22%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    2
    6
    0
    1
    0
    0
    0
    1
    0
    2
    0
    0
    3
    Hypotension
         subjects affected / exposed [123]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    3 / 44 (6.82%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    2
    3
    0
    0
    0
    1
    0
    1
    1
    3
    0
    1
    3
    Hot flush
         subjects affected / exposed [124]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    1
    1
    0
    0
    0
    Lymphoedema
         subjects affected / exposed [125]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    Orthostatic hypotension
         subjects affected / exposed [126]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Thrombosis
         subjects affected / exposed [127]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Surgical and medical procedures
    Central venous catheterisation
         subjects affected / exposed [128]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed [129]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    10 / 20 (50.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    5 / 18 (27.78%)
    2 / 40 (5.00%)
    12 / 40 (30.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    3 / 41 (7.32%)
    2 / 39 (5.13%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    1
    1
    21
    0
    4
    5
    3
    13
    3
    0
    4
    3
    4
    Administration site pain
         subjects affected / exposed [130]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Adverse drug reaction
         subjects affected / exposed [131]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Catheter site dermatitis
         subjects affected / exposed [132]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter site erosion
         subjects affected / exposed [133]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter site pain
         subjects affected / exposed [134]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Complication associated with device
         subjects affected / exposed [135]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chest pain
         subjects affected / exposed [136]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Chills
         subjects affected / exposed [137]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    8 / 44 (18.18%)
    3 / 41 (7.32%)
    5 / 39 (12.82%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    1
    3
    0
    0
    1
    1
    1
    0
    3
    11
    3
    5
    2
    Chest discomfort
         subjects affected / exposed [138]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    Cyst
         subjects affected / exposed [139]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Device related thrombosis
         subjects affected / exposed [140]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gait disturbance
         subjects affected / exposed [141]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    Facial pain
         subjects affected / exposed [142]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed [143]
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    7 / 18 (38.89%)
    14 / 18 (77.78%)
    1 / 20 (5.00%)
    2 / 3 (66.67%)
    2 / 18 (11.11%)
    4 / 18 (22.22%)
    7 / 40 (17.50%)
    11 / 40 (27.50%)
    20 / 40 (50.00%)
    11 / 44 (25.00%)
    8 / 41 (19.51%)
    14 / 39 (35.90%)
    6 / 37 (16.22%)
         occurrences all number
    3
    1
    9
    33
    1
    2
    2
    4
    7
    11
    22
    15
    9
    20
    6
    Early satiety
         subjects affected / exposed [144]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General physical health deterioration
         subjects affected / exposed [145]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Generalised oedema
         subjects affected / exposed [146]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Injection site discomfort
         subjects affected / exposed [147]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hernia pain
         subjects affected / exposed [148]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed [149]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    1 / 41 (2.44%)
    4 / 39 (10.26%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    2
    2
    0
    1
    0
    0
    1
    0
    1
    4
    1
    4
    1
    Hernia
         subjects affected / exposed [150]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Injection site induration
         subjects affected / exposed [151]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Localised oedema
         subjects affected / exposed [152]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed [153]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    1
    2
    0
    0
    2
    Medical device pain
         subjects affected / exposed [154]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Mucosal inflammation
         subjects affected / exposed [155]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    1
    4
    0
    0
    0
    0
    1
    3
    1
    0
    1
    1
    3
    Malaise
         subjects affected / exposed [156]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Oedema
         subjects affected / exposed [157]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed [158]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    2 / 18 (11.11%)
    2 / 18 (11.11%)
    4 / 40 (10.00%)
    4 / 40 (10.00%)
    3 / 40 (7.50%)
    5 / 44 (11.36%)
    1 / 41 (2.44%)
    3 / 39 (7.69%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    2
    4
    4
    4
    3
    5
    1
    4
    2
    Secretion discharge
         subjects affected / exposed [159]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed [160]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed [161]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    4 / 18 (22.22%)
    6 / 18 (33.33%)
    2 / 20 (10.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    2 / 18 (11.11%)
    8 / 40 (20.00%)
    8 / 40 (20.00%)
    6 / 40 (15.00%)
    15 / 44 (34.09%)
    6 / 41 (14.63%)
    14 / 39 (35.90%)
    6 / 37 (16.22%)
         occurrences all number
    0
    0
    4
    9
    2
    0
    3
    2
    9
    12
    6
    18
    9
    17
    8
    Pain
         subjects affected / exposed [162]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    Temperature intolerance
         subjects affected / exposed [163]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    7 / 18 (38.89%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    7
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Temperature regulation disorder
         subjects affected / exposed [164]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Xerosis
         subjects affected / exposed [165]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Infusion related hypersensitivity reaction
         subjects affected / exposed [166]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Anaphylactic reaction
         subjects affected / exposed [167]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed [168]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed [169]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed [170]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed [171]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Female genital tract fistula
         subjects affected / exposed [172]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Intermenstrual bleeding
         subjects affected / exposed [173]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    Menstruation irregular
         subjects affected / exposed [174]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oedema genital
         subjects affected / exposed [175]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Ovarian mass
         subjects affected / exposed [176]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vulvovaginal discomfort
         subjects affected / exposed [177]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed [178]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    6 / 40 (15.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    6
    1
    1
    1
    0
    Vaginal discharge
         subjects affected / exposed [179]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    4
    0
    0
    0
    0
    0
    Scrotal dermatitis
         subjects affected / exposed [180]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Postmenopausal haemorrhage
         subjects affected / exposed [181]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Pelvic pain
         subjects affected / exposed [182]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    Vulvovaginal dryness
         subjects affected / exposed [183]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vulvovaginal inflammation
         subjects affected / exposed [184]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed [185]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 40 (7.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    1
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed [186]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed [187]
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 18 (5.56%)
    5 / 18 (27.78%)
    6 / 20 (30.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    6 / 40 (15.00%)
    6 / 40 (15.00%)
    6 / 40 (15.00%)
    5 / 44 (11.36%)
    4 / 41 (9.76%)
    5 / 39 (12.82%)
    3 / 37 (8.11%)
         occurrences all number
    1
    1
    2
    12
    6
    0
    2
    0
    6
    6
    7
    5
    4
    6
    3
    Dry throat
         subjects affected / exposed [188]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dysphonia
         subjects affected / exposed [189]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cough
         subjects affected / exposed [190]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    3 / 18 (16.67%)
    2 / 18 (11.11%)
    9 / 20 (45.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    2 / 18 (11.11%)
    5 / 40 (12.50%)
    6 / 40 (15.00%)
    6 / 40 (15.00%)
    2 / 44 (4.55%)
    4 / 41 (9.76%)
    5 / 39 (12.82%)
    4 / 37 (10.81%)
         occurrences all number
    0
    1
    3
    3
    10
    0
    2
    5
    6
    7
    6
    2
    4
    7
    5
    Dyspnoea exertional
         subjects affected / exposed [191]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed [192]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    5 / 18 (27.78%)
    5 / 18 (27.78%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    6
    7
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Haemoptysis
         subjects affected / exposed [193]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    2
    1
    0
    Nasal congestion
         subjects affected / exposed [194]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    2
    3
    2
    4
    1
    0
    1
    1
    Hypoxia
         subjects affected / exposed [195]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Laryngeal haemorrhage
         subjects affected / exposed [196]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hiccups
         subjects affected / exposed [197]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Nasal dryness
         subjects affected / exposed [198]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasal ulcer
         subjects affected / exposed [199]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pleuritic pain
         subjects affected / exposed [200]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed [201]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    1
    1
    0
    0
    1
    Pleural effusion
         subjects affected / exposed [202]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    1 / 3 (33.33%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    2 / 44 (4.55%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    2
    0
    5
    2
    2
    0
    1
    Oropharyngeal discomfort
         subjects affected / exposed [203]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonitis
         subjects affected / exposed [204]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    3
    1
    1
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    Productive cough
         subjects affected / exposed [205]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    1
    1
    0
    0
    Pulmonary pain
         subjects affected / exposed [206]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pulmonary haemorrhage
         subjects affected / exposed [207]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pulmonary embolism
         subjects affected / exposed [208]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    1
    0
    1
    0
    2
    0
    0
    1
    0
    Respiratory tract congestion
         subjects affected / exposed [209]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed [210]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed [211]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    3
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    Sinus pain
         subjects affected / exposed [212]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed [213]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tachypnoea
         subjects affected / exposed [214]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Throat tightness
         subjects affected / exposed [215]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed [216]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed [217]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed [218]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    4
    0
    0
    4
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed [219]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    4 / 40 (10.00%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    0
    0
    1
    3
    4
    2
    0
    2
    1
    Confusional state
         subjects affected / exposed [220]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    Delirium
         subjects affected / exposed [221]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Depressed mood
         subjects affected / exposed [222]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Depression
         subjects affected / exposed [223]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    2
    2
    0
    0
    0
    1
    0
    Initial insomnia
         subjects affected / exposed [224]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hallucinations, mixed
         subjects affected / exposed [225]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed [226]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    5 / 40 (12.50%)
    1 / 40 (2.50%)
    4 / 40 (10.00%)
    5 / 44 (11.36%)
    3 / 41 (7.32%)
    3 / 39 (7.69%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    1
    6
    0
    0
    2
    1
    5
    1
    4
    5
    3
    3
    4
    Mood swings
         subjects affected / exposed [227]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Middle insomnia
         subjects affected / exposed [228]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability
         subjects affected / exposed [229]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervousness
         subjects affected / exposed [230]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Nightmare
         subjects affected / exposed [231]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Product issues
    Device occlusion
         subjects affected / exposed [232]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Investigations
    Amylase increased
         subjects affected / exposed [233]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    7 / 18 (38.89%)
    4 / 18 (22.22%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    5 / 44 (11.36%)
    1 / 41 (2.44%)
    3 / 39 (7.69%)
    4 / 37 (10.81%)
         occurrences all number
    0
    1
    14
    7
    0
    0
    0
    0
    2
    0
    1
    6
    3
    3
    4
    Activated partial thromboplastin time prolonged
         subjects affected / exposed [234]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    2
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed [235]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    3 / 18 (16.67%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    5 / 44 (11.36%)
    4 / 41 (9.76%)
    2 / 39 (5.13%)
    4 / 37 (10.81%)
         occurrences all number
    0
    1
    3
    2
    0
    0
    1
    3
    3
    4
    2
    5
    4
    2
    4
    Amylase
         subjects affected / exposed [236]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed [237]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    4 / 18 (22.22%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    4 / 41 (9.76%)
    4 / 39 (10.26%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    3
    4
    0
    0
    0
    1
    2
    0
    1
    5
    4
    7
    5
    Blood alkaline phosphatase increased
         subjects affected / exposed [238]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    5 / 44 (11.36%)
    4 / 41 (9.76%)
    3 / 39 (7.69%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    1
    1
    2
    3
    7
    4
    3
    4
    Blood albumin decreased
         subjects affected / exposed [239]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bacterial test positive
         subjects affected / exposed [240]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood cholesterol increased
         subjects affected / exposed [241]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    2
    4
    Aspartate aminotransferase increased
         subjects affected / exposed [242]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    4 / 18 (22.22%)
    5 / 18 (27.78%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    4 / 40 (10.00%)
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    8 / 44 (18.18%)
    8 / 41 (19.51%)
    6 / 39 (15.38%)
    6 / 37 (16.22%)
         occurrences all number
    0
    1
    4
    6
    0
    0
    2
    3
    4
    4
    2
    8
    11
    6
    10
    Blood glucose increased
         subjects affected / exposed [243]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Blood fibrinogen increased
         subjects affected / exposed [244]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed [245]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    1 / 3 (33.33%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    7 / 40 (17.50%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    3 / 39 (7.69%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    1
    1
    0
    1
    9
    2
    0
    3
    4
    Blood creatine increased
         subjects affected / exposed [246]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed [247]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    Blood pressure increased
         subjects affected / exposed [248]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood magnesium decreased
         subjects affected / exposed [249]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed [250]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    2
    0
    0
    0
    1
    Blood triglycerides increased
         subjects affected / exposed [251]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Blood uric acid decreased
         subjects affected / exposed [252]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Blood uric acid increased
         subjects affected / exposed [253]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Carbohydrate antigen 125 increased
         subjects affected / exposed [254]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed [255]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Eosinophil count increased
         subjects affected / exposed [256]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed [257]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    3 / 18 (16.67%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    5 / 40 (12.50%)
    3 / 44 (6.82%)
    5 / 41 (12.20%)
    2 / 39 (5.13%)
    5 / 37 (13.51%)
         occurrences all number
    0
    0
    4
    3
    1
    0
    0
    2
    2
    1
    5
    3
    5
    2
    7
    General physical condition abnormal
         subjects affected / exposed [258]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed [259]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed [260]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed [261]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    3 / 41 (7.32%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    3
    0
    2
    Lipase increased
         subjects affected / exposed [262]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    9 / 18 (50.00%)
    4 / 18 (22.22%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    8 / 44 (18.18%)
    3 / 41 (7.32%)
    2 / 39 (5.13%)
    6 / 37 (16.22%)
         occurrences all number
    0
    1
    14
    6
    1
    0
    0
    0
    2
    0
    0
    9
    5
    2
    14
    Tri-iodothyronine free decreased
         subjects affected / exposed [263]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Transaminases increased
         subjects affected / exposed [264]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed [265]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    1
    2
    1
    0
    1
    Neutrophil count decreased
         subjects affected / exposed [266]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    5 / 18 (27.78%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    7
    3
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed [267]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    3 / 44 (6.82%)
    3 / 41 (7.32%)
    1 / 39 (2.56%)
    5 / 37 (13.51%)
         occurrences all number
    0
    0
    3
    2
    0
    0
    0
    0
    0
    4
    2
    3
    3
    1
    10
    White blood cells urine positive
         subjects affected / exposed [268]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    White blood cell count decreased
         subjects affected / exposed [269]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    3
    4
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    4
    Weight increased
         subjects affected / exposed [270]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed [271]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    5 / 18 (27.78%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    4 / 44 (9.09%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    5
    3
    0
    0
    0
    0
    3
    1
    0
    6
    2
    1
    3
    Urine leukocyte esterase positive
         subjects affected / exposed [272]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    Troponin I increased
         subjects affected / exposed [273]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed [274]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Ankle fracture
         subjects affected / exposed [275]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Contusion
         subjects affected / exposed [276]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Fall
         subjects affected / exposed [277]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    3
    0
    0
    0
    0
    1
    0
    2
    1
    0
    0
    0
    Post-traumatic pain
         subjects affected / exposed [278]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Muscle strain
         subjects affected / exposed [279]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nail injury
         subjects affected / exposed [280]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed [281]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    9 / 44 (20.45%)
    9 / 41 (21.95%)
    2 / 39 (5.13%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    1
    1
    0
    2
    12
    9
    3
    4
    Procedural nausea
         subjects affected / exposed [282]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Procedural pain
         subjects affected / exposed [283]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    Stoma site pain
         subjects affected / exposed [284]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Spinal fracture
         subjects affected / exposed [285]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Stoma site discomfort
         subjects affected / exposed [286]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin laceration
         subjects affected / exposed [287]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Sunburn
         subjects affected / exposed [288]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Wound dehiscence
         subjects affected / exposed [289]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Wrist fracture
         subjects affected / exposed [290]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed [291]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Conduction disorder
         subjects affected / exposed [292]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cardiomegaly
         subjects affected / exposed [293]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bradycardia
         subjects affected / exposed [294]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed [295]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed [296]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Angina pectoris
         subjects affected / exposed [297]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Myocarditis
         subjects affected / exposed [298]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Palpitations
         subjects affected / exposed [299]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    1
    2
    0
    0
    0
    Pericardial effusion
         subjects affected / exposed [300]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed [301]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed [302]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    0
    1
    1
    1
    1
    0
    0
    0
    Ventricular tachycardia
         subjects affected / exposed [303]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Central nervous system necrosis
         subjects affected / exposed [304]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cerebrospinal fluid leakage
         subjects affected / exposed [305]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Amnesia
         subjects affected / exposed [306]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Ataxia
         subjects affected / exposed [307]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Balance disorder
         subjects affected / exposed [308]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Burning sensation
         subjects affected / exposed [309]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Cognitive disorder
         subjects affected / exposed [310]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Disturbance in attention
         subjects affected / exposed [311]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed [312]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    5 / 18 (27.78%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    3
    5
    0
    1
    0
    0
    0
    0
    2
    1
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed [313]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dysarthria
         subjects affected / exposed [314]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed [315]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    6 / 18 (33.33%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    5 / 40 (12.50%)
    3 / 44 (6.82%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    1
    0
    2
    7
    1
    0
    0
    1
    1
    0
    5
    3
    2
    2
    2
    Encephalomalacia
         subjects affected / exposed [316]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Facial paralysis
         subjects affected / exposed [317]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed [318]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    0
    Hypersomnia
         subjects affected / exposed [319]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Hypoaesthesia
         subjects affected / exposed [320]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    Headache
         subjects affected / exposed [321]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    6 / 18 (33.33%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    0 / 18 (0.00%)
    7 / 40 (17.50%)
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    12 / 44 (27.27%)
    17 / 41 (41.46%)
    8 / 39 (20.51%)
    8 / 37 (21.62%)
         occurrences all number
    1
    0
    0
    7
    1
    0
    3
    0
    8
    0
    5
    13
    19
    9
    9
    Lhermitte's sign
         subjects affected / exposed [322]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Loss of consciousness
         subjects affected / exposed [323]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neuralgia
         subjects affected / exposed [324]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Metabolic encephalopathy
         subjects affected / exposed [325]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Migraine
         subjects affected / exposed [326]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Memory impairment
         subjects affected / exposed [327]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed [328]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    11 / 18 (61.11%)
    10 / 18 (55.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    14
    12
    0
    0
    0
    0
    2
    1
    1
    2
    1
    1
    1
    Paraesthesia
         subjects affected / exposed [329]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    4
    0
    0
    1
    0
    1
    1
    1
    2
    0
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed [330]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    5 / 18 (27.78%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    6
    1
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    0
    Speech disorder
         subjects affected / exposed [331]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Seizure
         subjects affected / exposed [332]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed [333]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Presyncope
         subjects affected / exposed [334]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Syncope
         subjects affected / exposed [335]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Taste disorder
         subjects affected / exposed [336]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Tremor
         subjects affected / exposed [337]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed [338]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    3 / 18 (16.67%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    2 / 40 (5.00%)
    10 / 40 (25.00%)
    9 / 40 (22.50%)
    4 / 44 (9.09%)
    1 / 41 (2.44%)
    6 / 39 (15.38%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    4
    7
    1
    0
    2
    1
    2
    10
    11
    4
    1
    7
    5
    Thrombocytopenia
         subjects affected / exposed [339]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    Neutropenia
         subjects affected / exposed [340]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    6 / 18 (33.33%)
    8 / 18 (44.44%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    8
    15
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed [341]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed [342]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed [343]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Thrombocytosis
         subjects affected / exposed [344]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed [345]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Deafness
         subjects affected / exposed [346]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Ear pain
         subjects affected / exposed [347]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Ear pruritus
         subjects affected / exposed [348]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Tinnitus
         subjects affected / exposed [349]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Middle ear effusion
         subjects affected / exposed [350]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Otorrhoea
         subjects affected / exposed [351]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hypoacusis
         subjects affected / exposed [352]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed [353]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Amaurosis fugax
         subjects affected / exposed [354]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Blepharospasm
         subjects affected / exposed [355]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed [356]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Diplopia
         subjects affected / exposed [357]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed [358]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Eye discharge
         subjects affected / exposed [359]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye irritation
         subjects affected / exposed [360]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    Dry eye
         subjects affected / exposed [361]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    1
    0
    0
    1
    1
    1
    1
    2
    Eye pruritus
         subjects affected / exposed [362]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Eyelids pruritus
         subjects affected / exposed [363]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Photophobia
         subjects affected / exposed [364]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed [365]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    Periorbital oedema
         subjects affected / exposed [366]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed [367]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pterygium
         subjects affected / exposed [368]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed [369]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 44 (6.82%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    3
    0
    3
    0
    0
    5
    0
    0
    0
    Vitreous floaters
         subjects affected / exposed [370]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Visual impairment
         subjects affected / exposed [371]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed [372]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    1
    Abdominal distension
         subjects affected / exposed [373]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    6 / 44 (13.64%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    1
    1
    5
    7
    1
    1
    1
    Abdominal hernia
         subjects affected / exposed [374]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Abdominal pain lower
         subjects affected / exposed [375]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    2
    0
    0
    2
    0
    Abdominal pain
         subjects affected / exposed [376]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    6 / 18 (33.33%)
    4 / 18 (22.22%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    2 / 18 (11.11%)
    3 / 18 (16.67%)
    10 / 40 (25.00%)
    8 / 40 (20.00%)
    5 / 40 (12.50%)
    7 / 44 (15.91%)
    7 / 41 (17.07%)
    5 / 39 (12.82%)
    2 / 37 (5.41%)
         occurrences all number
    2
    0
    6
    4
    0
    3
    2
    3
    10
    9
    5
    7
    7
    5
    2
    Abdominal pain upper
         subjects affected / exposed [377]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    0
    1
    1
    4
    0
    0
    0
    0
    0
    1
    1
    1
    1
    0
    3
    Anal incontinence
         subjects affected / exposed [378]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Anal haemorrhage
         subjects affected / exposed [379]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    Abdominal rigidity
         subjects affected / exposed [380]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Anorectal discomfort
         subjects affected / exposed [381]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Ascites
         subjects affected / exposed [382]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    4 / 40 (10.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    3
    2
    5
    1
    1
    2
    1
    Constipation
         subjects affected / exposed [383]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    5 / 18 (27.78%)
    2 / 20 (10.00%)
    0 / 3 (0.00%)
    9 / 18 (50.00%)
    2 / 18 (11.11%)
    7 / 40 (17.50%)
    9 / 40 (22.50%)
    4 / 40 (10.00%)
    10 / 44 (22.73%)
    7 / 41 (17.07%)
    4 / 39 (10.26%)
    1 / 37 (2.70%)
         occurrences all number
    1
    0
    3
    5
    2
    0
    9
    2
    8
    9
    4
    12
    8
    5
    1
    Colitis
         subjects affected / exposed [384]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Autoimmune pancreatitis
         subjects affected / exposed [385]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Defaecation urgency
         subjects affected / exposed [386]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Epigastric discomfort
         subjects affected / exposed [387]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dysphagia
         subjects affected / exposed [388]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 20 (10.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed [389]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    2 / 44 (4.55%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    4
    0
    2
    2
    1
    0
    0
    Dry mouth
         subjects affected / exposed [390]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    3 / 44 (6.82%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    1
    0
    1
    3
    1
    3
    0
    1
    0
    Diarrhoea
         subjects affected / exposed [391]
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    6 / 18 (33.33%)
    8 / 18 (44.44%)
    6 / 20 (30.00%)
    1 / 3 (33.33%)
    5 / 18 (27.78%)
    2 / 18 (11.11%)
    6 / 40 (15.00%)
    10 / 40 (25.00%)
    10 / 40 (25.00%)
    9 / 44 (20.45%)
    5 / 41 (12.20%)
    5 / 39 (12.82%)
    7 / 37 (18.92%)
         occurrences all number
    3
    2
    8
    24
    7
    1
    5
    2
    6
    12
    11
    12
    7
    8
    10
    Eructation
         subjects affected / exposed [392]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed [393]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    1
    2
    3
    0
    0
    1
    1
    Food poisoning
         subjects affected / exposed [394]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed [395]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed [396]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed [397]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed [398]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    1
    2
    0
    1
    1
    1
    0
    2
    Glossodynia
         subjects affected / exposed [399]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Ileus
         subjects affected / exposed [400]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed [401]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperaesthesia teeth
         subjects affected / exposed [402]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed [403]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    3 / 41 (7.32%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    3
    1
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed [404]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed [405]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Melaena
         subjects affected / exposed [406]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed [407]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Lip dry
         subjects affected / exposed [408]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Impaired gastric emptying
         subjects affected / exposed [409]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed [410]
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    10 / 18 (55.56%)
    12 / 18 (66.67%)
    3 / 20 (15.00%)
    0 / 3 (0.00%)
    4 / 18 (22.22%)
    4 / 18 (22.22%)
    9 / 40 (22.50%)
    13 / 40 (32.50%)
    16 / 40 (40.00%)
    8 / 44 (18.18%)
    8 / 41 (19.51%)
    9 / 39 (23.08%)
    7 / 37 (18.92%)
         occurrences all number
    2
    1
    10
    26
    4
    0
    7
    4
    10
    17
    17
    9
    9
    12
    8
    Odynophagia
         subjects affected / exposed [411]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Rectal discharge
         subjects affected / exposed [412]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Proctitis
         subjects affected / exposed [413]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Proctalgia
         subjects affected / exposed [414]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Paraesthesia oral
         subjects affected / exposed [415]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oral pain
         subjects affected / exposed [416]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    6 / 18 (33.33%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    6
    0
    1
    0
    1
    0
    1
    0
    0
    0
    1
    0
    Rectal haemorrhage
         subjects affected / exposed [417]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    1
    Rectal tenesmus
         subjects affected / exposed [418]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Rectal spasm
         subjects affected / exposed [419]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Retroperitoneal haemorrhage
         subjects affected / exposed [420]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Small intestinal obstruction
         subjects affected / exposed [421]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed [422]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    5 / 18 (27.78%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    6 / 44 (13.64%)
    1 / 41 (2.44%)
    3 / 39 (7.69%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    7
    3
    0
    0
    0
    0
    2
    1
    0
    8
    1
    3
    3
    Toothache
         subjects affected / exposed [423]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Umbilical hernia
         subjects affected / exposed [424]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed [425]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    7 / 18 (38.89%)
    4 / 20 (20.00%)
    1 / 3 (33.33%)
    5 / 18 (27.78%)
    1 / 18 (5.56%)
    8 / 40 (20.00%)
    10 / 40 (25.00%)
    6 / 40 (15.00%)
    7 / 44 (15.91%)
    8 / 41 (19.51%)
    7 / 39 (17.95%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    3
    8
    4
    1
    9
    1
    13
    10
    7
    8
    8
    9
    1
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed [426]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed [427]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed [428]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    Cholelithiasis
         subjects affected / exposed [429]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed [430]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    Alopecia
         subjects affected / exposed [431]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    6 / 18 (33.33%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    2
    7
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    1
    Dermatomyositis
         subjects affected / exposed [432]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Drug eruption
         subjects affected / exposed [433]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed [434]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    5 / 18 (27.78%)
    2 / 18 (11.11%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    3 / 44 (6.82%)
    5 / 41 (12.20%)
    2 / 39 (5.13%)
    10 / 37 (27.03%)
         occurrences all number
    0
    0
    5
    2
    1
    0
    1
    0
    1
    0
    2
    3
    5
    2
    10
    Blister
         subjects affected / exposed [435]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dermatitis
         subjects affected / exposed [436]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed [437]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    8 / 18 (44.44%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    28 / 44 (63.64%)
    24 / 41 (58.54%)
    20 / 39 (51.28%)
    23 / 37 (62.16%)
         occurrences all number
    0
    0
    15
    1
    0
    0
    0
    1
    2
    0
    2
    41
    24
    21
    25
    Hypertrichosis
         subjects affected / exposed [438]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    3 / 41 (7.32%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    3
    0
    0
    Hyperhidrosis
         subjects affected / exposed [439]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    2 / 44 (4.55%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    4
    2
    0
    0
    Hirsutism
         subjects affected / exposed [440]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed [441]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    2
    0
    1
    0
    0
    Eczema
         subjects affected / exposed [442]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Ecchymosis
         subjects affected / exposed [443]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed [444]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Intertrigo
         subjects affected / exposed [445]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Lichen planus
         subjects affected / exposed [446]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Madarosis
         subjects affected / exposed [447]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Miliaria
         subjects affected / exposed [448]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail discolouration
         subjects affected / exposed [449]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain of skin
         subjects affected / exposed [450]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Onychoclasis
         subjects affected / exposed [451]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Onychalgia
         subjects affected / exposed [452]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Night sweats
         subjects affected / exposed [453]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    Nail pigmentation
         subjects affected / exposed [454]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail disorder
         subjects affected / exposed [455]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed [456]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    4 / 18 (22.22%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    3 / 44 (6.82%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    3
    4
    0
    0
    0
    0
    0
    0
    1
    3
    0
    1
    0
    Photosensitivity reaction
         subjects affected / exposed [457]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 44 (6.82%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    Petechiae
         subjects affected / exposed [458]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed [459]
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    4 / 18 (22.22%)
    3 / 18 (16.67%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    7 / 40 (17.50%)
    3 / 40 (7.50%)
    7 / 40 (17.50%)
    12 / 44 (27.27%)
    8 / 41 (19.51%)
    6 / 39 (15.38%)
    7 / 37 (18.92%)
         occurrences all number
    1
    3
    8
    3
    1
    0
    0
    0
    7
    3
    7
    15
    10
    6
    11
    Pruritus allergic
         subjects affected / exposed [460]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Psoriasis
         subjects affected / exposed [461]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed [462]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    9 / 18 (50.00%)
    3 / 18 (16.67%)
    1 / 20 (5.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    4 / 18 (22.22%)
    5 / 40 (12.50%)
    3 / 40 (7.50%)
    3 / 40 (7.50%)
    5 / 44 (11.36%)
    8 / 41 (19.51%)
    12 / 39 (30.77%)
    9 / 37 (24.32%)
         occurrences all number
    0
    4
    14
    3
    1
    1
    0
    4
    5
    4
    3
    9
    8
    14
    9
    Rash maculo-papular
         subjects affected / exposed [463]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    4 / 44 (9.09%)
    5 / 41 (12.20%)
    6 / 39 (15.38%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    8
    1
    0
    0
    2
    0
    3
    0
    3
    6
    5
    6
    4
    Rash macular
         subjects affected / exposed [464]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    4
    Rash pruritic
         subjects affected / exposed [465]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin discolouration
         subjects affected / exposed [466]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed [467]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Rash vesicular
         subjects affected / exposed [468]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Skin disorder
         subjects affected / exposed [469]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin erosion
         subjects affected / exposed [470]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin hyperpigmentation
         subjects affected / exposed [471]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin fissures
         subjects affected / exposed [472]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    3 / 44 (6.82%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    3
    2
    1
    1
    Skin exfoliation
         subjects affected / exposed [473]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    0
    Skin lesion
         subjects affected / exposed [474]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Skin reaction
         subjects affected / exposed [475]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin toxicity
         subjects affected / exposed [476]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin ulcer
         subjects affected / exposed [477]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Trichorrhexis
         subjects affected / exposed [478]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed [479]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin mass
         subjects affected / exposed [480]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed [481]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bladder irritation
         subjects affected / exposed [482]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bladder pain
         subjects affected / exposed [483]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Chromaturia
         subjects affected / exposed [484]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    1
    1
    1
    0
    Haematuria
         subjects affected / exposed [485]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    4 / 18 (22.22%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    3 / 44 (6.82%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    4
    1
    1
    1
    2
    3
    2
    1
    3
    Dysuria
         subjects affected / exposed [486]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Hydronephrosis
         subjects affected / exposed [487]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    1
    0
    0
    Proteinuria
         subjects affected / exposed [488]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    5
    Pollakiuria
         subjects affected / exposed [489]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    1
    1
    2
    0
    0
    2
    1
    Nocturia
         subjects affected / exposed [490]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    Hypertonic bladder
         subjects affected / exposed [491]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Renal failure
         subjects affected / exposed [492]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal infarct
         subjects affected / exposed [493]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Renal tubular necrosis
         subjects affected / exposed [494]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Urinary fistula
         subjects affected / exposed [495]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Urinary incontinence
         subjects affected / exposed [496]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    3
    1
    0
    0
    1
    0
    Urinary retention
         subjects affected / exposed [497]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    1
    0
    Urine flow decreased
         subjects affected / exposed [498]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Urinary tract pain
         subjects affected / exposed [499]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Urinary tract obstruction
         subjects affected / exposed [500]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed [501]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    4 / 40 (10.00%)
    2 / 40 (5.00%)
    4 / 40 (10.00%)
    6 / 44 (13.64%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    5 / 37 (13.51%)
         occurrences all number
    1
    0
    3
    1
    0
    1
    1
    2
    4
    2
    4
    7
    1
    1
    7
    Hyperthyroidism
         subjects affected / exposed [502]
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    1
    1
    0
    1
    2
    0
    1
    0
    Euthyroid sick syndrome
         subjects affected / exposed [503]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Adrenal insufficiency
         subjects affected / exposed [504]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Thyroid mass
         subjects affected / exposed [505]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Thyroiditis
         subjects affected / exposed [506]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed [507]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    2
    0
    1
    0
    1
    1
    1
    1
    0
    Bone pain
         subjects affected / exposed [508]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed [509]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    3 / 18 (16.67%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    6 / 40 (15.00%)
    5 / 40 (12.50%)
    6 / 40 (15.00%)
    6 / 44 (13.64%)
    5 / 41 (12.20%)
    4 / 39 (10.26%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    4
    1
    0
    1
    3
    6
    5
    6
    7
    5
    4
    2
    Arthritis
         subjects affected / exposed [510]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    16
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed [511]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    2 / 18 (11.11%)
    3 / 20 (15.00%)
    0 / 3 (0.00%)
    3 / 18 (16.67%)
    4 / 18 (22.22%)
    6 / 40 (15.00%)
    4 / 40 (10.00%)
    5 / 40 (12.50%)
    4 / 44 (9.09%)
    4 / 41 (9.76%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    4
    5
    3
    0
    4
    5
    7
    4
    5
    4
    4
    3
    1
    Gouty arthritis
         subjects affected / exposed [512]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Groin pain
         subjects affected / exposed [513]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    1
    1
    1
    Muscle spasms
         subjects affected / exposed [514]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    5
    0
    1
    1
    0
    1
    2
    0
    2
    0
    0
    0
    Muscular weakness
         subjects affected / exposed [515]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    3 / 44 (6.82%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    5
    0
    0
    2
    0
    1
    0
    1
    3
    0
    1
    2
    Musculoskeletal chest pain
         subjects affected / exposed [516]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    3 / 20 (15.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    1
    0
    0
    2
    1
    0
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed [517]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed [518]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    4 / 20 (20.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    1
    0
    3
    0
    1
    1
    0
    0
    1
    Myalgia
         subjects affected / exposed [519]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    2 / 20 (10.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    4 / 40 (10.00%)
    4 / 40 (10.00%)
    1 / 40 (2.50%)
    9 / 44 (20.45%)
    0 / 41 (0.00%)
    6 / 39 (15.38%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    3
    3
    0
    2
    1
    4
    4
    1
    10
    0
    6
    1
    Neck mass
         subjects affected / exposed [520]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed [521]
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed [522]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    3 / 44 (6.82%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    4
    3
    2
    1
    0
    Pain in jaw
         subjects affected / exposed [523]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sacral pain
         subjects affected / exposed [524]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Temporomandibular joint syndrome
         subjects affected / exposed [525]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Spondylitis
         subjects affected / exposed [526]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Abdominal infection
         subjects affected / exposed [527]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Abscess
         subjects affected / exposed [528]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Bacteraemia
         subjects affected / exposed [529]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    Bacteriuria
         subjects affected / exposed [530]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Biliary tract infection
         subjects affected / exposed [531]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Breast abscess
         subjects affected / exposed [532]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed [533]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    2 / 20 (10.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Candida infection
         subjects affected / exposed [534]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed [535]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    Clostridium bacteraemia
         subjects affected / exposed [536]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed [537]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed [538]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    2
    0
    Cystitis
         subjects affected / exposed [539]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Cystitis pseudomonal
         subjects affected / exposed [540]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Device related infection
         subjects affected / exposed [541]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Diverticulitis
         subjects affected / exposed [542]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Enterocolitis infectious
         subjects affected / exposed [543]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Escherichia sepsis
         subjects affected / exposed [544]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed [545]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Eye infection
         subjects affected / exposed [546]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed [547]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed [548]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Gingivitis
         subjects affected / exposed [549]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Herpes zoster
         subjects affected / exposed [550]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Hordeolum
         subjects affected / exposed [551]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    Infection
         subjects affected / exposed [552]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed [553]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    3
    0
    1
    0
    0
    0
    0
    Keratitis viral
         subjects affected / exposed [554]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Kidney infection
         subjects affected / exposed [555]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Lip infection
         subjects affected / exposed [556]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed [557]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Medical device site infection
         subjects affected / exposed [558]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Mucosal infection
         subjects affected / exposed [559]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nail infection
         subjects affected / exposed [560]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed [561]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 40 (7.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed [562]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 44 (2.27%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    2
    1
    1
    1
    1
    Oral fungal infection
         subjects affected / exposed [563]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 20 (10.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed [564]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Oral infection
         subjects affected / exposed [565]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Otitis externa
         subjects affected / exposed [566]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Paronychia
         subjects affected / exposed [567]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    4 / 18 (22.22%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    4 / 44 (9.09%)
    4 / 41 (9.76%)
    1 / 39 (2.56%)
    6 / 37 (16.22%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    4
    4
    1
    6
    Penile infection
         subjects affected / exposed [568]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Peritonitis
         subjects affected / exposed [569]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed [570]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    Pneumonia aspiration
         subjects affected / exposed [571]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Pyuria
         subjects affected / exposed [572]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Rash pustular
         subjects affected / exposed [573]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    4 / 44 (9.09%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed [574]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    3 / 20 (15.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed [575]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    Sepsis
         subjects affected / exposed [576]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed [577]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed [578]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Staphylococcal skin infection
         subjects affected / exposed [579]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Streptococcal infection
         subjects affected / exposed [580]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Tooth infection
         subjects affected / exposed [581]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed [582]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tooth abscess
         subjects affected / exposed [583]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Tinea pedis
         subjects affected / exposed [584]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed [585]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 44 (4.55%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    4
    1
    1
    0
    0
    2
    0
    3
    2
    Urinary tract infection
         subjects affected / exposed [586]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    4 / 18 (22.22%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    1 / 40 (2.50%)
    7 / 40 (17.50%)
    3 / 40 (7.50%)
    3 / 44 (6.82%)
    4 / 41 (9.76%)
    3 / 39 (7.69%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    6
    0
    0
    1
    3
    1
    9
    3
    3
    4
    3
    1
    Vaginal infection
         subjects affected / exposed [587]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    Urinary tract infection fungal
         subjects affected / exposed [588]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Adult failure to thrive
         subjects affected / exposed [589]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Cachexia
         subjects affected / exposed [590]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Decreased appetite
         subjects affected / exposed [591]
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    5 / 18 (27.78%)
    8 / 18 (44.44%)
    3 / 20 (15.00%)
    1 / 3 (33.33%)
    4 / 18 (22.22%)
    4 / 18 (22.22%)
    7 / 40 (17.50%)
    5 / 40 (12.50%)
    14 / 40 (35.00%)
    9 / 44 (20.45%)
    5 / 41 (12.20%)
    10 / 39 (25.64%)
    5 / 37 (13.51%)
         occurrences all number
    2
    0
    6
    11
    3
    1
    4
    4
    9
    5
    14
    9
    6
    11
    6
    Dehydration
         subjects affected / exposed [592]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    4 / 18 (22.22%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    4
    0
    0
    0
    1
    1
    0
    0
    1
    2
    2
    0
    Electrolyte imbalance
         subjects affected / exposed [593]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Failure to thrive
         subjects affected / exposed [594]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gout
         subjects affected / exposed [595]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hyperamylasaemia
         subjects affected / exposed [596]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed [597]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed [598]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Hypercreatininaemia
         subjects affected / exposed [599]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hyperkalaemia
         subjects affected / exposed [600]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 44 (4.55%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    4
    1
    1
    1
    Hyperglycaemia
         subjects affected / exposed [601]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    3 / 40 (7.50%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    3
    1
    0
    0
    2
    Hyperlipasaemia
         subjects affected / exposed [602]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed [603]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    1 / 20 (5.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 44 (2.27%)
    3 / 41 (7.32%)
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    2
    1
    2
    0
    0
    0
    1
    2
    1
    2
    3
    2
    6
    Hyperphosphataemia
         subjects affected / exposed [604]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hypermagnesaemia
         subjects affected / exposed [605]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed [606]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    2 / 44 (4.55%)
    1 / 41 (2.44%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    3
    3
    1
    2
    1
    Hypervolaemia
         subjects affected / exposed [607]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed [608]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    3 / 44 (6.82%)
    4 / 41 (9.76%)
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    0
    0
    1
    0
    4
    4
    2
    2
    Hypocalcaemia
         subjects affected / exposed [609]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    6 / 44 (13.64%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    8
    0
    0
    4
    Hypochloraemia
         subjects affected / exposed [610]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoglycaemia
         subjects affected / exposed [611]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed [612]
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 18 (11.11%)
    3 / 18 (16.67%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    4 / 40 (10.00%)
    5 / 44 (11.36%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    5 / 37 (13.51%)
         occurrences all number
    1
    0
    3
    3
    0
    0
    0
    0
    2
    3
    6
    7
    2
    2
    6
    Hypomagnesaemia
         subjects affected / exposed [613]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    4 / 18 (22.22%)
    1 / 18 (5.56%)
    0 / 20 (0.00%)
    1 / 3 (33.33%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    5 / 40 (12.50%)
    3 / 40 (7.50%)
    9 / 44 (20.45%)
    8 / 41 (19.51%)
    3 / 39 (7.69%)
    10 / 37 (27.03%)
         occurrences all number
    0
    0
    7
    1
    0
    1
    0
    0
    0
    7
    3
    13
    8
    4
    21
    Hypophosphataemia
         subjects affected / exposed [614]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Hypophagia
         subjects affected / exposed [615]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Hyponatraemia
         subjects affected / exposed [616]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 40 (5.00%)
    4 / 40 (10.00%)
    3 / 40 (7.50%)
    5 / 44 (11.36%)
    6 / 41 (14.63%)
    2 / 39 (5.13%)
    4 / 37 (10.81%)
         occurrences all number
    0
    0
    3
    3
    0
    0
    0
    0
    2
    4
    4
    5
    8
    3
    5
    Iron deficiency
         subjects affected / exposed [617]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed [618]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Malnutrition
         subjects affected / exposed [619]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Metabolic acidosis
         subjects affected / exposed [620]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Polydipsia
         subjects affected / exposed [621]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed [622]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed [623]
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 20 (0.00%)
    0 / 3 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Notes
    [111] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [112] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [113] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [114] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [115] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [116] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [117] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [118] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [119] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [120] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [121] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [122] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [123] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [124] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [125] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [126] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [127] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [128] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [129] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [130] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [131] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [132] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [133] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [134] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [135] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [136] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [137] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [138] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [139] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [140] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [141] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [142] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [143] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [144] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [145] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [146] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [147] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [148] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [149] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [150] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [151] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [152] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [153] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [154] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [155] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [156] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [157] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [158] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [159] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [160] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [161] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [162] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [163] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [164] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [165] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [166] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [167] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [168] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [169] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [170] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [171] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [172] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [173] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [174] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [175] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [176] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [177] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [178] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [179] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [180] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [181] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [182] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [183] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [184] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [185] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [186] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [187] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [188] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [189] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [190] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [191] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [192] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [193] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [194] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [195] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [196] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [197] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [198] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [199] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [200] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [201] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [202] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [203] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [204] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [205] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [206] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [207] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [208] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [209] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [210] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [211] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [212] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [213] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [214] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [215] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [216] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [217] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [218] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [219] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [220] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [221] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [222] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [223] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [224] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [225] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [226] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [227] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [228] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [229] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [230] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [231] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [232] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [233] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [234] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [235] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [236] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [237] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [238] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [239] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [240] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [241] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [242] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [243] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [244] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [245] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [246] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [247] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [248] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [249] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [250] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [251] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [252] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [253] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [254] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [255] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [256] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [257] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [258] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [259] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [260] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [261] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [262] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [263] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [264] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [265] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [266] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [267] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [268] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [269] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [270] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [271] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [272] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [273] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [274] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [275] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [276] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [277] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [278] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [279] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [280] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [281] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [282] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [283] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [284] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [285] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [286] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [287] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [288] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [289] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [290] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [291] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [292] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [293] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [294] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [295] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [296] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [297] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [298] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [299] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [300] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [301] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [302] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [303] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [304] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [305] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [306] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [307] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [308] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [309] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [310] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [311] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [312] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [313] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [314] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [315] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [316] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [317] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [318] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [319] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [320] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [321] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [322] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [323] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [324] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [325] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [326] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [327] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [328] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [329] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [330] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [331] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [332] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [333] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [334] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [335] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [336] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [337] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [338] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [339] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [340] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [341] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [342] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [343] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [344] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [345] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [346] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [347] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [348] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [349] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [350] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [351] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [352] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [353] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [354] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [355] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [356] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [357] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [358] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [359] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [360] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [361] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [362] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [363] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [364] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [365] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [366] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [367] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [368] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [369] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [370] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [371] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [372] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [373] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [374] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [375] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [376] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [377] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [378] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [379] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [380] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [381] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [382] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [383] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [384] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [385] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [386] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [387] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [388] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [389] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [390] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [391] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [392] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [393] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [394] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [395] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [396] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [397] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [398] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [399] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [400] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [401] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [402] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [403] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [404] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [405] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [406] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [407] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [408] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [409] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [410] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [411] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [412] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [413] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [414] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [415] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [416] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [417] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [418] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [419] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [420] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [421] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [422] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [423] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [424] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [425] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [426] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [427] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [428] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [429] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [430] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [431] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [432] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [433] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [434] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [435] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [436] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [437] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [438] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [439] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [440] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [441] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [442] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [443] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [444] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [445] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [446] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [447] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [448] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [449] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [450] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [451] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [452] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [453] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [454] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [455] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [456] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [457] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [458] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [459] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [460] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [461] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [462] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [463] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [464] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [465] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [466] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [467] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [468] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [469] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [470] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [471] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [472] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [473] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [474] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [475] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [476] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [477] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [478] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [479] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [480] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [481] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [482] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [483] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [484] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [485] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [486] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [487] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [488] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [489] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [490] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [491] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [492] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [493] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [494] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [495] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [496] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [497] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [498] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [499] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [500] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [501] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [502] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [503] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [504] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [505] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [506] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [507] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [508] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [509] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [510] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [511] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [512] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [513] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [514] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [515] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [516] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [517] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [518] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [519] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [520] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [521] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [522] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [523] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [524] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [525] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [526] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [527] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [528] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [529] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [530] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [531] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [532] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [533] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [534] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [535] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [536] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [537] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [538] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [539] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [540] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [541] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [542] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [543] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [544] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [545] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [546] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [547] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [548] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [549] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [550] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [551] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [552] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [553] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [554] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [555] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [556] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [557] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [558] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [559] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [560] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [561] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [562] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [563] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [564] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [565] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [566] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [567] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [568] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [569] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [570] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [571] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [572] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [573] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [574] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [575] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [576] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [577] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [578] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [579] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [580] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [581] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [582] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [583] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [584] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [585] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [586] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [587] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [588] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [589] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [590] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [591] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [592] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [593] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [594] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [595] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [596] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [597] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [598] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [599] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [600] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [601] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [602] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [603] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [604] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [605] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [606] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [607] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [608] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [609] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [610] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [611] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [612] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [613] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [614] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [615] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [616] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [617] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [618] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [619] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [620] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [621] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [622] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed
    [623] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In AE section death data was analysed as per ITT population and AE/SAE data was analysed as per As-treated population. Hence, for Cohort C1A “Number of subjects exposed” for each adverse event is less than the “Total number of subjects exposed

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2016
    The dose limiting toxicity (DLT) definition was modified to include any Grade 3/4 laboratory abnormality requiring hospitalization for the management of toxicities and any delays in monalizumab dosing due to a treatment-related AE. Exclusions were added to the DLT definition: Grade 3 nausea/vomiting or Grade 4 vomiting in the absence of maximal medical therapy that resolves in 3 days, and Grade 3 hypertension that can be controlled with medical therapy. Inclusion criteria were updated to require: Advanced ovarian cancer participants to have previously received and progressed while on or within 6 months of completing a platinum-based regimen, and metastatic castration-resistant prostate cancer participants to have progressed from either abiraterone or enzalutamide. Appendix 2, Management of Study Medication Related Toxicities was revised to require permanent discontinuation of study drugs if immune-mediated neurotoxicities were not resolved to =< Grade 1 within 14 days.
    10 Jan 2018
    Revised the study design (Section 3) to include Part 3 (dose exploration part of the study), cohorts A and B. The primary hypothesis, study objectives and endpoints, rationale, inclusion and exclusion criteria, and sample size were revised to support the addition of Part 3 of the study. Assessment of tumor response, in the Exploratory Analysis of Tumor Response section, was changed from irRECIST to iRECIST.
    31 Aug 2018
    New exploration cohorts were added to Part 3 to evaluate monalizumab with cetuximab in participants with 3L MSS-CRC that is RAS/BRAF wild type (Part 3, cohort C2B) as well as RAS mutant (Part 3, cohort C1B). Study treatments administered were revised to include durvalumab in combination with monalizumab plus cetuximab in participants with 3L MSS-CRC that is RAS mutant (Part 3, cohort C1A) as well as RAS/BRAF wild type (Part 3, cohort C2A). Specified maximum time of treatment in study was 3 years.
    22 Feb 2019
    Secondary objectives and associated endpoints revised to include EGFR expression in pretreatment tumor biopsies. In exploratory objectives, endpoints specified mass spectrometry, DNA/RNA/miRNA assessments. Potential biomarkers were updated to include epigenetic and metabolic assessments on blood and tumors as well as microbiome assessments on baseline stool samples. Added new presentation of monalizumab 375 mg/vial (20 mL vial). Revised prior therapy inclusion criteria for Part 3 C cohorts. Updated the process for identifying and reporting potential Hy's Law and Hy's Law cases.
    06 Dec 2019
    Information on management of study medication-related toxicities was moved to a standalone document and reference made to Section 3.1.3 of the CSP for details. A new section to Study Methods and Schedules of Procedures was added to allow re-treatment following relapse. Participants who progressed during the first 52 weeks after the last dose of study treatment were eligible for re-treatment with the protocol-defined experimental medicines. The investigator could consider standard-of-care chemotherapy backbone with the experimental agent(s) as appropriate for the participant at time of re-treatment.
    31 May 2021
    Added measures to implement if a participant was not able to visit a study site (Section 3.3 and Section 10.6). Details on the presentation of monalizumab according to vial size were updated. The link to the Toxicity Management Guidance portal was removed.

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

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