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    Clinical Trial Results:
    An Open-Label, Multicenter, Dose-Escalation Phase Ib Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Selicrelumab (CD40 Agonist) in Combination with Atezolizumab (Anti-PDL1) in Patients with Locally Advanced and/or Metastatic Solid Tumors.

    Summary
    EudraCT number
    		 2014-002835-32
    Trial protocol
    		 ES   FR  
    Global end of trial date
    07 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Nov 2020
    First version publication date
    15 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BP29392
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02304393
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4070
    Public contact
    F. Hoffmann-La Roche AG, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.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
    07 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this trial was to assess the safety, pharmacokinetics, pharmacodynamics, and activity of selicrelumab administered in combination with atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors.
    Protection of trial subjects
    All participants were required to sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Denmark: 16
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    France: 53
    Country: Number of subjects enrolled
    Netherlands: 35
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    140
    EEA total number of subjects
    124
    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)
    94
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult participants with metastatic or locally advanced solid tumors not amenable to standard therapies.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV)
    Arm description
    		 Participants received a fixed-dose of 16 mg intravenous (IV) selicrelumab in combination with 1200 mg of IV atezolizumab (ATZ).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV selicrelumab at a fixed dose of 16 mg on Cycle 1 Day 1.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab Q3W starting Cycle 2 Day 1, or escalating doses of atezolizumab Q4W up to 1200 mg.

    Arm title
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC)
    Arm description
    		 Participants received 1 mg of subcutaneous (SC) selicrelumab in combination with 1200 mg of IV ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab Q3W starting Cycle 2 Day 1.

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 1.

    Arm title
    		 Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC)
    Arm description
    		 Participants received 2 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 1.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab Q3W starting Cycle 2 Day 1.

    Arm title
    		 Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC)
    Arm description
    		 Participants received 16 mg of SC selicrelumab in combination with 1200 mg of ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab Q3W starting Cycle 2 Day 1.

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 1.

    Arm title
    		 Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Arm description
    		 Participants received 32 mg of SC selicrelumab in combination with 1200 mg of ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 1.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab Q3W starting Cycle 2 Day 1.

    Arm title
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC)
    Arm description
    		 Participants received up to 9 mg of SC selicrelumab in combination with 1200 mg of ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab on Cycle 1 Day 1, and Q3W thereafter.

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 2.

    Arm title
    		 Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC)
    Arm description
    		 Participants received 12-21 mg of SC selicrelumab in combination with 1200 mg of ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 2.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab on Cycle 1 Day 1, and Q3W thereafter.

    Arm title
    		 Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC)
    Arm description
    		 Participants received 28-36 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 2.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab on Cycle 1 Day 1, and Q3W thereafter.

    Arm title
    		 Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Arm description
    		 Participants received 48-64 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received escalating doses of SC selicrelumab on Cycle 1 Day 2.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab on Cycle 1 Day 1, and Q3W thereafter.

    Arm title
    		 Part 2 (SC): Small + Large Bowel Carcinoma
    Arm description
    		 Participants with small and large bowel carcinoma received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab on Cycle 1 Day 1, and Q3W thereafter.

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 16 mg of SC selicrelumab for 4 administrations starting Cycle 1, then Q12W thereafter.

    Arm title
    		 Part 2 (SC): HNSCC
    Arm description
    		 Participants with head and neck squamous cell carcinoma (HNSCC) received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 16 mg of SC selicrelumab for 4 administrations starting Cycle 1, then Q12W thereafter.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab on Cycle 1 Day 1, and Q3W thereafter.

    Arm title
    		 Part 2 (SC): NSCLC
    Arm description
    		 Participants with non-small cell lung cancer received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selicrelumab
    Investigational medicinal product code
    Other name
    RO7009789
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 16 mg of SC selicrelumab for 4 administrations starting Cycle 1, then Q12W thereafter.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    RO5541267
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 1200 mg of IV atezolizumab on Cycle 1 Day 1, and Q3W thereafter.

    Number of subjects in period 1
    		Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC) Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Started
    6
    5
    7
    8
    4
    31
    16
    9
    9
    12
    19
    14
    Completed
    6
    5
    7
    8
    4
    31
    16
    9
    9
    12
    19
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV)
    Reporting group description
    		 Participants received a fixed-dose of 16 mg intravenous (IV) selicrelumab in combination with 1200 mg of IV atezolizumab (ATZ).

    Reporting group title
    Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC)
    Reporting group description
    		 Participants received 1 mg of subcutaneous (SC) selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC)
    Reporting group description
    		 Participants received 2 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC)
    Reporting group description
    		 Participants received 16 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Reporting group description
    		 Participants received 32 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC)
    Reporting group description
    		 Participants received up to 9 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC)
    Reporting group description
    		 Participants received 12-21 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC)
    Reporting group description
    		 Participants received 28-36 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Reporting group description
    		 Participants received 48-64 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): Small + Large Bowel Carcinoma
    Reporting group description
    		 Participants with small and large bowel carcinoma received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): HNSCC
    Reporting group description
    		 Participants with head and neck squamous cell carcinoma (HNSCC) received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): NSCLC
    Reporting group description
    		 Participants with non-small cell lung cancer received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC) Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC Total
    Number of subjects
    		 6 5 7 8 4 31 16 9 9 12 19 14 140
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 3 3 6 5 3 24 12 4 6 6 12 10 94
        From 65-84 years
    		 3 2 1 3 1 7 4 5 3 6 7 4 46
        85 years and over
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.7 ± 13.6 54.0 ± 20.1 48.1 ± 13.9 54.5 ± 13.0 52.0 ± 15.5 56.7 ± 9.8 53.4 ± 15.8 59.1 ± 16.8 56.4 ± 12.2 63.1 ± 8.3 60.9 ± 11.1 60.4 ± 8.5 -
    Gender Categorical
    Units: Subjects
        Female
    		 2 3 5 2 2 19 7 6 6 6 6 6 70
        Male
    		 4 2 2 6 2 12 9 3 3 6 13 8 70
    Race
    Units: Subjects
        Asian
    		 0 0 2 0 0 1 1 1 0 0 0 0 5
        White
    		 6 2 4 5 3 14 8 3 6 7 7 1 66
        Unknown
    		 0 3 1 3 1 16 7 5 3 5 12 13 69
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0 5 2 0 0 2 0 0 9
        Not Hispanic or Latino
    		 6 1 3 5 3 8 6 4 6 5 7 1 55
        Not Stated
    		 0 2 2 3 1 10 4 2 0 2 6 9 41
        Unknown
    		 0 2 2 0 0 8 4 3 3 3 6 4 35

    End points

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    End points reporting groups
    Reporting group title
    Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV)
    Reporting group description
    		 Participants received a fixed-dose of 16 mg intravenous (IV) selicrelumab in combination with 1200 mg of IV atezolizumab (ATZ).

    Reporting group title
    Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC)
    Reporting group description
    		 Participants received 1 mg of subcutaneous (SC) selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC)
    Reporting group description
    		 Participants received 2 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC)
    Reporting group description
    		 Participants received 16 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Reporting group description
    		 Participants received 32 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC)
    Reporting group description
    		 Participants received up to 9 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC)
    Reporting group description
    		 Participants received 12-21 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC)
    Reporting group description
    		 Participants received 28-36 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Reporting group description
    		 Participants received 48-64 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): Small + Large Bowel Carcinoma
    Reporting group description
    		 Participants with small and large bowel carcinoma received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): HNSCC
    Reporting group description
    		 Participants with head and neck squamous cell carcinoma (HNSCC) received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): NSCLC
    Reporting group description
    		 Participants with non-small cell lung cancer received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 1 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 2 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 4 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 6 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 9 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 12 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 16 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 21 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 28 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 32 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 36 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 48 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Subject analysis set title
    Pharmacokinetic (PK) Analysis Population - 64 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.

    Primary: Number of Participants with Adverse Events (AEs) and Serious AEs

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    End point title
    		 Number of Participants with Adverse Events (AEs) and Serious AEs [1]
    End point description
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
    End point type
    Primary
    End point timeframe
    Up to approximately 59 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    End point values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC) Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    6
    5
    7
    8
    4
    31
    16
    9
    9
    12
    19
    14
    Units: Number of Participants
    number (not applicable)
        AEs
    5
    5
    7
    8
    4
    31
    16
    9
    9
    12
    19
    14
        SAEs
    2
    2
    5
    1
    1
    9
    5
    3
    4
    4
    4
    6
    No statistical analyses for this end point

    Primary: Part IB: Maximum Tolerated Dose (MTD) of Selicrelumab

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    End point title
    		 Part IB: Maximum Tolerated Dose (MTD) of Selicrelumab [2] [3]
    End point description
    The MTD was not reached and is not reported.
    End point type
    Primary
    End point timeframe
    Cycle 1 Day 1 - Cycle 2 Day 2 (cycle length = 21 days)
    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: No formal statistical analyses were planned for this phase 1 study.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31 [4]
    16 [5]
    9 [6]
    9 [7]
    Units: mg
        number (not applicable)
    9999
    9999
    9999
    9999
    Notes
    [4] - 9999 = The MTD was not reached and is not reported.
    [5] - 9999 = The MTD was not reached and is not reported.
    [6] - 999 = The MTD was not reached and is not reported.
    [7] - 999 = The MTD was not reached and is not reported.
    No statistical analyses for this end point

    Primary: Part IB: Recommended Part II Dose of Selicrelumab

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    End point title
    		 Part IB: Recommended Part II Dose of Selicrelumab [8] [9]
    End point description
    The dose for Part II was to be defined based on the MTD established in Part IB. Since the MTD was not reached, the recommended dose of selicrelumab was based on available safety and tolerability data. The values reported are the maximum dose provided in each arm.
    End point type
    Primary
    End point timeframe
    Cycle 1 Day 1 - Cycle 2 Day 2 (cycle length = 21 days)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31
    16
    9
    9
    Units: mg
        number (not applicable)
    9
    21
    36
    64
    No statistical analyses for this end point

    Primary: Part IB: Number of Participants with Dose-Limiting Toxicities (DLTs)

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    End point title
    		 Part IB: Number of Participants with Dose-Limiting Toxicities (DLTs) [10] [11]
    End point description
    A DLT was defined as a protocol-defined toxicity related to selicrelumab and/or atezolizumab that occurred during the DLT-assessment window.
    End point type
    Primary
    End point timeframe
    Day 1 of Cycles 2, 3, 4, and 5
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31
    16
    9
    9
    Units: Number of Participants
    2
    1
    0
    1
    No statistical analyses for this end point

    Primary: Part II: Percentage of Participants With Best Overall Response (BOR), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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    End point title
    		 Part II: Percentage of Participants With Best Overall Response (BOR), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [12] [13]
    End point description
    BOR was defined as a best response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
    End point type
    Primary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months)
    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: No formal statistical analyses were planned for this phase 1 study.
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    12
    19
    14
    Units: Percentage of Participants
    number (confidence interval 95%)
        CR
    0.00 (0.00 to 0.00)
    5.3 (0.00 to 15.30)
    0 (0.00 to 0.00)
        PR
    0 (0.00 to 0.00)
    10.5 (0.00 to 24.33)
    0 (0.00 to 0.00)
        SD
    0 (0.00 to 0.00)
    26.3 (6.52 to 46.12)
    57.1 (31.22 to 83.07)
        PD
    100.0 (100.00 to 100.00)
    42.1 (19.90 to 64.31)
    35.7 (10.61 to 60.81)
    No statistical analyses for this end point

    Primary: Part II: Progression-Free Survival (PFS), as Determined by Investigator Using RECIST Version 1.1

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    End point title
    		 Part II: Progression-Free Survival (PFS), as Determined by Investigator Using RECIST Version 1.1 [14] [15]
    End point description
    PFS was defined as the time from the first study treatment to the first occurrence of disease progression or death, whichever occurred first.
    End point type
    Primary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months).
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    12
    19
    14
    Units: Days
        median (confidence interval 95%)
    38.0 (37.0 to 39.0)
    48.0 (37.0 to 122.0)
    81.0 (38.0 to 127.0)
    No statistical analyses for this end point

    Primary: Part II: Duration of Objective Response (DOR), as Determined by Investigator Using RECIST v1.1

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    End point title
    		 Part II: Duration of Objective Response (DOR), as Determined by Investigator Using RECIST v1.1 [16] [17]
    End point description
    DOR was defined as the time from the first occurrence of a documented objective response to the time of relapse or death from any cause, whichever occurred first.
    End point type
    Primary
    End point timeframe
    First occurence of response to relapse or death from any cause, whichever occurred first (up to 58 months).
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [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: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    12 [18]
    19
    14 [19]
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    483.0 (232.0 to 533.0)
    9999 (9999 to 9999)
    Notes
    [18] - 9999 = Data missing or unevaluable.
    [19] - 9999 = Data missing or unevaluable.
    No statistical analyses for this end point

    Primary: Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using RECIST Version 1.1

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    End point title
    		 Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using RECIST Version 1.1 [20] [21]
    End point description
    Disease control rate (DCR) was defined as CR, PR, or SD lasting at least 6 weeks (per RECIST v1.1)
    End point type
    Primary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [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: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    12 [22]
    19
    14
    Units: Percentage of Participants
        number (not applicable)
    9999
    31.6
    35.7
    Notes
    [22] - 9999 = Data missing or unevaluable
    No statistical analyses for this end point

    Primary: Part II: Overall Survival (OS)

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    End point title
    		 Part II: Overall Survival (OS) [23] [24]
    End point description
    OS was defined as the time from first study treatment to death. Overall survival was not summarized for this study.
    End point type
    Primary
    End point timeframe
    Baseline to death from any cause (up to approximately 58 months)
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [25]
    0 [26]
    0 [27]
    Units: N/A
        number (not applicable)
    Notes
    [25] - Overall survival was not summarized for this study.
    [26] - Overall survival was not summarized for this study.
    [27] - Overall survival was not summarized for this study.
    No statistical analyses for this end point

    Primary: Part II: PFS, as Determined by Investigator Using Unidimensional irRC

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    End point title
    		 Part II: PFS, as Determined by Investigator Using Unidimensional irRC [28] [29]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Primary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    Units: N/A
        number (not applicable)
    Notes
    [30] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [31] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [32] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Primary: Part II: Percentage of Participants With BOR, as Determined by Investigator Using Unidimensional Immune-Related Response Criteria (irRC)

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    End point title
    		 Part II: Percentage of Participants With BOR, as Determined by Investigator Using Unidimensional Immune-Related Response Criteria (irRC) [33] [34]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Primary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [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: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [35]
    0 [36]
    0 [37]
    Units: N/A
        number (not applicable)
    Notes
    [35] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [36] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [37] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Primary: Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using Unidimensional irRC

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    End point title
    		 Part II: Percentage of Participants With Disease Control, as Determined by Investigator Using Unidimensional irRC [38] [39]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Primary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [40]
    0 [41]
    0 [42]
    Units: N/A
        number (not applicable)
    Notes
    [40] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [41] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [42] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Primary: Part II: DOR, as Determined by Investigator Using Unidimensional irRC

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    End point title
    		 Part II: DOR, as Determined by Investigator Using Unidimensional irRC [43] [44]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Primary
    End point timeframe
    Baseline to progressive disease or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were planned for this phase 1 study.
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [45]
    0 [46]
    0 [47]
    Units: N/A
        number (not applicable)
    Notes
    [45] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [46] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [47] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Time Curve (AUC) of Selicrelumab (Single SC Dose)

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    End point title
    		 Area Under the Concentration Time Curve (AUC) of Selicrelumab (Single SC Dose)
    End point description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (cycle = 21 days)
    End point values
    		 Pharmacokinetic (PK) Analysis Population - 1 mg Pharmacokinetic (PK) Analysis Population - 2 mg Pharmacokinetic (PK) Analysis Population - 4 mg Pharmacokinetic (PK) Analysis Population - 6 mg Pharmacokinetic (PK) Analysis Population - 9 mg Pharmacokinetic (PK) Analysis Population - 12 mg Pharmacokinetic (PK) Analysis Population - 16 mg Pharmacokinetic (PK) Analysis Population - 21 mg Pharmacokinetic (PK) Analysis Population - 28 mg Pharmacokinetic (PK) Analysis Population - 32 mg Pharmacokinetic (PK) Analysis Population - 36 mg Pharmacokinetic (PK) Analysis Population - 48 mg Pharmacokinetic (PK) Analysis Population - 64 mg
    Number of subjects analysed
    5
    11
    10
    4
    5
    5
    56
    7
    4
    4
    5
    4
    5
    Units: ug*h/mL
        geometric mean (geometric coefficient of variation)
    3.45 ± 30
    4.06 ± 49
    4.80 ± 71
    15.37 ± 29
    10.15 ± 63
    16.18 ± 59
    36.76 ± 47
    33.98 ± 51
    70.74 ± 29
    85.20 ± 46
    86.01 ± 10
    111.63 ± 25
    178.55 ± 28
    No statistical analyses for this end point

    Secondary: Maximum Serum Concentration (Cmax) of Selicrelumab (Single SC Dose)

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    End point title
    		 Maximum Serum Concentration (Cmax) of Selicrelumab (Single SC Dose)
    End point description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (cycle = 21 days)
    End point values
    		 Pharmacokinetic (PK) Analysis Population - 1 mg Pharmacokinetic (PK) Analysis Population - 2 mg Pharmacokinetic (PK) Analysis Population - 4 mg Pharmacokinetic (PK) Analysis Population - 6 mg Pharmacokinetic (PK) Analysis Population - 9 mg Pharmacokinetic (PK) Analysis Population - 12 mg Pharmacokinetic (PK) Analysis Population - 16 mg Pharmacokinetic (PK) Analysis Population - 21 mg Pharmacokinetic (PK) Analysis Population - 28 mg Pharmacokinetic (PK) Analysis Population - 32 mg Pharmacokinetic (PK) Analysis Population - 36 mg Pharmacokinetic (PK) Analysis Population - 48 mg Pharmacokinetic (PK) Analysis Population - 64 mg
    Number of subjects analysed
    5
    11
    10
    4
    5
    5
    56
    7
    4
    4
    5
    4
    5
    Units: ug/mL
        geometric mean (geometric coefficient of variation)
    0.0004 ± 80
    0.0010 ± 100
    0.0026 ± 107
    0.0014 ± 100
    0.0046 ± 126
    0.0105 ± 50
    0.0159 ± 75
    0.0097 ± 105
    0.0173 ± 59
    0.0172 ± 89
    0.0204 ± 59
    0.0089 ± 104
    0.0382 ± 80
    No statistical analyses for this end point

    Secondary: Time to Cmax (Tmax) of Selicrelumab (Single SC Dose)

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    End point title
    		 Time to Cmax (Tmax) of Selicrelumab (Single SC Dose)
    End point description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (cycle = 21 days)
    End point values
    		 Pharmacokinetic (PK) Analysis Population - 1 mg Pharmacokinetic (PK) Analysis Population - 2 mg Pharmacokinetic (PK) Analysis Population - 4 mg Pharmacokinetic (PK) Analysis Population - 6 mg Pharmacokinetic (PK) Analysis Population - 9 mg Pharmacokinetic (PK) Analysis Population - 12 mg Pharmacokinetic (PK) Analysis Population - 16 mg Pharmacokinetic (PK) Analysis Population - 21 mg Pharmacokinetic (PK) Analysis Population - 28 mg Pharmacokinetic (PK) Analysis Population - 32 mg Pharmacokinetic (PK) Analysis Population - 36 mg Pharmacokinetic (PK) Analysis Population - 48 mg Pharmacokinetic (PK) Analysis Population - 64 mg
    Number of subjects analysed
    5
    11
    10
    4
    5
    5
    56
    7
    4
    4
    5
    4
    5
    Units: Hours
        median (full range (min-max))
    72.12 (47.83 to 501.92)
    481.20 (68.58 to 523.23)
    71.57 (24.07 to 486.55)
    71.19 (69.75 to 481.33)
    48.07 (46.32 to 71.25)
    478.80 (46.50 to 480.47)
    144.12 (46.67 to 484.38)
    48.53 (46.13 to 484.32)
    70.85 (48.93 to 480.15)
    163.12 (69.17 to 360.67)
    163.50 (47.58 to 452.08)
    120.91 (70.23 to 482.33)
    167.42 (71.75 to 505.72)
    No statistical analyses for this end point

    Secondary: Minimum Serum Concentration Under Steady-State (Cmin) of Selicrelumab (Single SC Dose)

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    End point title
    		 Minimum Serum Concentration Under Steady-State (Cmin) of Selicrelumab (Single SC Dose)
    End point description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (cycle = 21 days)
    End point values
    		 Pharmacokinetic (PK) Analysis Population - 1 mg Pharmacokinetic (PK) Analysis Population - 2 mg Pharmacokinetic (PK) Analysis Population - 4 mg Pharmacokinetic (PK) Analysis Population - 6 mg Pharmacokinetic (PK) Analysis Population - 9 mg Pharmacokinetic (PK) Analysis Population - 12 mg Pharmacokinetic (PK) Analysis Population - 16 mg Pharmacokinetic (PK) Analysis Population - 21 mg Pharmacokinetic (PK) Analysis Population - 28 mg Pharmacokinetic (PK) Analysis Population - 32 mg Pharmacokinetic (PK) Analysis Population - 36 mg Pharmacokinetic (PK) Analysis Population - 48 mg Pharmacokinetic (PK) Analysis Population - 64 mg
    Number of subjects analysed
    5
    11
    10
    4
    5
    5
    56
    7
    4
    4
    5
    4
    5
    Units: ug/mL
        geometric mean (geometric coefficient of variation)
    0.0004 ± 80
    0.0010 ± 100
    0.0033 ± 127
    0.0014 ± 100
    0.0046 ± 126
    0.0105 ± 50
    0.0165 ± 73
    0.0097 ± 105
    0.0173 ± 59
    0.0172 ± 89
    0.0204 ± 59
    0.0089 ± 104
    0.0382 ± 80
    No statistical analyses for this end point

    Secondary: Part IA: Cmax of Atezolizumab

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    End point title
    		 Part IA: Cmax of Atezolizumab [48]
    End point description
    The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1a, therefore other arms were excluded.
    End point values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Number of subjects analysed
    0 [49]
    0 [50]
    0 [51]
    0 [52]
    0 [53]
    Units: N/A
        number (not applicable)
    Notes
    [49] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [50] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [51] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [52] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [53] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    No statistical analyses for this end point

    Secondary: Part IA: Cmin of Atezolizumab

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    End point title
    		 Part IA: Cmin of Atezolizumab [54]
    End point description
    The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1a, therefore other arms were excluded.
    End point values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Number of subjects analysed
    0 [55]
    0 [56]
    0 [57]
    0 [58]
    0 [59]
    Units: N/A
        number (not applicable)
    Notes
    [55] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [56] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [57] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [58] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [59] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    No statistical analyses for this end point

    Secondary: AUC of SC Selicrelumab (Repeated SC Dose)

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    End point title
    		 AUC of SC Selicrelumab (Repeated SC Dose)
    End point description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Cycles 1-7 (cycle = 21 days)
    End point values
    		 Pharmacokinetic (PK) Analysis Population - 16 mg
    Number of subjects analysed
    56
    Units: ug*h/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 (n= 56)
    36.76 ± 47
        Cycle 2 (n= 30)
    55.65 ± 41
        Cycle 3 (n=15)
    58.95 ± 41
        Cycle 4 (n=10)
    79.92 ± 37
        Cycle 5 (n= 8)
    73.14 ± 38
        Cycle 6 (n=6)
    71.85 ± 43
        Cycle 7 (n=5)
    58.18 ± 28
    No statistical analyses for this end point

    Secondary: Cmax of SC Selicrelumab (Repeated SC Dose)

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    End point title
    		 Cmax of SC Selicrelumab (Repeated SC Dose)
    End point description
    PK data from participants who received at least one dose of selicrelumab were included in the treatment's PK analysis. Participants that significantly violated exclusion criteria, deviated significantly from the protocol, or that had unavailable or incomplete data were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Cycles 1-7 (cycle = 21 days)
    End point values
    		 Pharmacokinetic (PK) Analysis Population - 16 mg
    Number of subjects analysed
    56
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1 (n=56)
    0.0159 ± 75
        Cycle 2 (n=30)
    0.0233 ± 45
        Cycle 3 (n=15)
    0.0274 ± 42
        Cycle 4 (n=10)
    0.0106 ± 52
        Cycle 5 (n=8)
    0.0105 ± 57
        Cycle 6 (n=6)
    0.0104 ± 50
        Cycle 7 (n=5)
    0.0095 ± 50
    No statistical analyses for this end point

    Secondary: Part IB: Cmax of Atezolizumab

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    End point title
    		 Part IB: Cmax of Atezolizumab [60]
    End point description
    The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    Units: N/A
        number (not applicable)
    Notes
    [61] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [62] - The pharmacokinetics for atezolizumab were not derived and hence are not reported. .
    [63] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [64] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    No statistical analyses for this end point

    Secondary: Part IB: Cmin of Atezolizumab

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    End point title
    		 Part IB: Cmin of Atezolizumab [65]
    End point description
    The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [66]
    0 [67]
    0 [68]
    0 [69]
    Units: N/A
        number (not applicable)
    Notes
    [66] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [67] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [68] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [69] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    No statistical analyses for this end point

    Secondary: Part II: Cmax of Atezolizumab

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    End point title
    		 Part II: Cmax of Atezolizumab [70]
    End point description
    The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [71]
    0 [72]
    0 [73]
    Units: N/A
        number (not applicable)
    Notes
    [71] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [72] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [73] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    No statistical analyses for this end point

    Secondary: Part II: Cmin of Atezolizumab

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    End point title
    		 Part II: Cmin of Atezolizumab [74]
    End point description
    The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [75]
    0 [76]
    0 [77]
    Units: N/A
        number (not applicable)
    Notes
    [75] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [76] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    [77] - The pharmacokinetics for atezolizumab were not derived and hence are not reported.
    No statistical analyses for this end point

    Secondary: Part IB: Percentage of Participants With BOR, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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    End point title
    		 Part IB: Percentage of Participants With BOR, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [78]
    End point description
    BOR was defined as a best response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
    End point type
    Secondary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurs first (up to approximately 58 months)
    Notes
    [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31
    16
    9
    9
    Units: Percentage of Participants
    number (confidence interval 95%)
        CR
    0 (0.00 to 0.00)
    0 (0.00 to 0.00)
    0 (0.00 to 0.00)
    0 (0.00 to 0.00)
        PR
    9.7 (0.00 to 20.08)
    6.3 (0.00 to 18.11)
    33.3 (2.54 to 64.13)
    0 (0.00 to 0.00)
        SD
    45.2 (27.64 to 62.68)
    25.0 (3.78 to 46.22)
    44.4 (11.98 to 76.91)
    77.8 (50.62 to 100.00)
        PD
    29.0 (13.05 to 45.01)
    56.3 (31.94 to 80.56)
    22.2 (0.00 to 49.38)
    22.2 (0.00 to 49.38)
    No statistical analyses for this end point

    Secondary: Part IB: Percentage of Participants With Disease Control, as Determined by Investigator Using RECIST Version 1.1

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    End point title
    		 Part IB: Percentage of Participants With Disease Control, as Determined by Investigator Using RECIST Version 1.1 [79]
    End point description
    Disease control rate (DCR) was defined as CR, PR, or SD lasting at least 6 weeks (per RECIST v1.1)
    End point type
    Secondary
    End point timeframe
    Baseline to disease progression or death to any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31
    16
    9
    9
    Units: Percentage of Participants
        number (not applicable)
    38.7
    18.8
    55.6
    33.3
    No statistical analyses for this end point

    Secondary: Part IB: DOR, as Determined by Investigator Using RECIST Version 1.1

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    End point title
    		 Part IB: DOR, as Determined by Investigator Using RECIST Version 1.1 [80]
    End point description
    DOR was defined as the time from the first occurrence of a documented objective response to the time of relapse or death from any cause, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    First occurrence of response to relapse or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31
    16 [81]
    9
    9 [82]
    Units: Days
        median (confidence interval 95%)
    230.0 (212.0 to 570.0)
    676.0 (0 to 9999)
    340.0 (81.0 to 534.0)
    9999 (9999 to 9999)
    Notes
    [81] - 9999 = Data missing or unevaluable
    [82] - 9999 = Data missing or unevaluable
    No statistical analyses for this end point

    Secondary: Part IB: PFS, as Determined by Investigator Using RECIST Version 1.1

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    End point title
    		 Part IB: PFS, as Determined by Investigator Using RECIST Version 1.1 [83]
    End point description
    PFS was defined as the time from the first study treatment to the first occurrence of disease progression or death, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [83] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded. No formal statistical analyses were planned for this phase 1 study.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31
    16
    9
    9
    Units: Days
        median (confidence interval 95%)
    82.0 (42.0 to 178.0)
    37.0 (35.0 to 78.0)
    119.0 (94.0 to 165.0)
    82.0 (79.0 to 121.0)
    No statistical analyses for this end point

    Secondary: Part IA: Levels of Circulating Ki67 T cells Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part IA: Levels of Circulating Ki67 T cells Assessed by Immunophenotyping by Flow Cytometry [84]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1a, therefore other arms were excluded.
    End point values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Number of subjects analysed
    0 [85]
    0 [86]
    0 [87]
    0 [88]
    0 [89]
    Units: N/A
        number (not applicable)
    Notes
    [85] - No pharmacodynamic results are reported due to premature study discontinuation.
    [86] - No pharmacodynamic results are reported due to premature study discontinuation.
    [87] - No pharmacodynamic results are reported due to premature study discontinuation.
    [88] - No pharmacodynamic results are reported due to premature study discontinuation.
    [89] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part IB: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part IB: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry [90]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [91]
    0 [92]
    0 [93]
    0 [94]
    Units: N/A
        number (not applicable)
    Notes
    [91] - No pharmacodynamic results are reported due to premature study discontinuation.
    [92] - No pharmacodynamic results are reported due to premature study discontinuation.
    [93] - No pharmacodynamic results are reported due to premature study discontinuation.
    [94] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part II: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part II: Levels of Circulating Ki67 T Cells Assessed by Immunophenotyping by Flow Cytometry [95]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [96]
    0 [97]
    0 [98]
    Units: N/A
        number (not applicable)
    Notes
    [96] - No pharmacodynamic results are reported due to premature study discontinuation.
    [97] - No pharmacodynamic results are reported due to premature study discontinuation.
    [98] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part IA: Levels of Cluster of Differentiation 8 (CD8+) Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part IA: Levels of Cluster of Differentiation 8 (CD8+) Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry [99]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [99] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1a, therefore other arms were excluded.
    End point values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Number of subjects analysed
    0 [100]
    0 [101]
    0 [102]
    0 [103]
    0 [104]
    Units: N/A
        number (not applicable)
    Notes
    [100] - No pharmacodynamic results are reported due to premature study discontinuation.
    [101] - No pharmacodynamic results are reported due to premature study discontinuation.
    [102] - No pharmacodynamic results are reported due to premature study discontinuation.
    [103] - No pharmacodynamic results are reported due to premature study discontinuation.
    [104] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part IB: Levels of CD8+ Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part IB: Levels of CD8+ Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry [105]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [105] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [106]
    0 [107]
    0 [108]
    0 [109]
    Units: N/A
        number (not applicable)
    Notes
    [106] - No pharmacodynamic results are reported due to premature study discontinuation.
    [107] - No pharmacodynamic results are reported due to premature study discontinuation.
    [108] - No pharmacodynamic results are reported due to premature study discontinuation.
    [109] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part IA: Levels of Programmed Death Ligand 1 (PD-L1) Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part IA: Levels of Programmed Death Ligand 1 (PD-L1) Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry [110]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1a, therefore other arms were excluded.
    End point values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Number of subjects analysed
    0 [111]
    0 [112]
    0 [113]
    0 [114]
    0 [115]
    Units: N/A
        number (not applicable)
    Notes
    [111] - No pharmacodynamic results are reported due to premature study discontinuation.
    [112] - No pharmacodynamic results are reported due to premature study discontinuation.
    [113] - No pharmacodynamic results are reported due to premature study discontinuation.
    [114] - No pharmacodynamic results are reported due to premature study discontinuation.
    [115] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part IB: Levels of PD-L1 Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part IB: Levels of PD-L1 Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry [116]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [116] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [117]
    0 [118]
    0 [119]
    0 [120]
    Units: N/A
        number (not applicable)
    Notes
    [117] - No pharmacodynamic results are reported due to premature study discontinuation.
    [118] - No pharmacodynamic results are reported due to premature study discontinuation.
    [119] - No pharmacodynamic results are reported due to premature study discontinuation.
    [120] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part II: Levels of PD-L1 Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part II: Levels of PD-L1 Expression on Both Tumor and Immune-Infiltrating Cells Assessed by Immunophenotyping by Flow Cytometry [121]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [121] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [122]
    0 [123]
    0 [124]
    Units: N/A
        number (not applicable)
    Notes
    [122] - No pharmacodynamic results are reported due to premature study discontinuation.
    [123] - No pharmacodynamic results are reported due to premature study discontinuation.
    [124] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part II: Levels of CD8+ Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry

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    End point title
    		 Part II: Levels of CD8+ Cells Tumor-Infiltration Assessed by Immunophenotyping by Flow Cytometry [125]
    End point description
    No pharmacodynamic results are reported due to premature study discontinuation.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [125] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    0 [126]
    0 [127]
    0 [128]
    Units: N/A
        number (not applicable)
    Notes
    [126] - No pharmacodynamic results are reported due to premature study discontinuation.
    [127] - No pharmacodynamic results are reported due to premature study discontinuation.
    [128] - No pharmacodynamic results are reported due to premature study discontinuation.
    No statistical analyses for this end point

    Secondary: Part IA: Percentage of Participants with Incidence of Anti-Drug Antibodies (ADA) Responses to Selicrelumab

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    End point title
    		 Part IA: Percentage of Participants with Incidence of Anti-Drug Antibodies (ADA) Responses to Selicrelumab [129]
    End point description
    Samples from participants treated with selicrelumab and atezolizumab were analyzed for ADAs.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [129] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1a, therefore other arms were excluded.
    End point values
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Number of subjects analysed
    6
    5
    7
    8
    4
    Units: Percentage of Participants
    number (not applicable)
        Treatment-induced ADAs
    0
    0
    14.3
    0
    0
        Treatment-enhanced ADAs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part IB: Percentage of Participants with Incidence of ADA Responses to Selicrelumab

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    End point title
    		 Part IB: Percentage of Participants with Incidence of ADA Responses to Selicrelumab [130]
    End point description
    Samples from participants treated with selicrelumab and atezolizumab were analyzed for ADAs.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [130] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    31
    16
    9
    9
    Units: Percentage of participants
    number (not applicable)
        Treatment-induced ADA
    6.5
    12.5
    11.1
    0
        Treatment-enhanced ADA
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part II: Percentage of Participants with Incidence of ADA Responses to Selicrelumab

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    End point title
    		 Part II: Percentage of Participants with Incidence of ADA Responses to Selicrelumab [131]
    End point description
    Samples from participants treated with selicrelumab and atezolizumab were analyzed for ADAs.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [131] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 2, therefore other arms were excluded.
    End point values
    		 Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): HNSCC Part 2 (SC): NSCLC
    Number of subjects analysed
    12
    19
    14
    Units: Percentage of Participants
    number (not applicable)
        Treatment-induced ADA
    0
    0
    0
        Treatment-enhanced ADA
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part IB: Percentage of Participants With BOR, as Determined by Investigator Using Unidimensional Immune-Related Response Criteria (irRC)

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    End point title
    		 Part IB: Percentage of Participants With BOR, as Determined by Investigator Using Unidimensional Immune-Related Response Criteria (irRC) [132]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Secondary
    End point timeframe
    Baseline to disease progression or death from any cause, whichever occurred first (up to approximately 58 months)
    Notes
    [132] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [133]
    0 [134]
    0 [135]
    0 [136]
    Units: Percentage of Participants
        number (not applicable)
    Notes
    [133] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [134] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [135] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [136] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Secondary: Part Ib: Duration of Objective Response, as Determined by Investigator Using Unidimensional irRC

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    End point title
    		 Part Ib: Duration of Objective Response, as Determined by Investigator Using Unidimensional irRC [137]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [137] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [138]
    0 [139]
    0 [140]
    0 [141]
    Units: N/A
        number (not applicable)
    Notes
    [138] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [139] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [140] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [141] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Secondary: Part Ib: Percentage of Participants With Disease Control, as Determined by Investigator Using Unidimensional irRC

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    End point title
    		 Part Ib: Percentage of Participants With Disease Control, as Determined by Investigator Using Unidimensional irRC [142]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [142] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [143]
    0 [144]
    0 [145]
    0 [146]
    Units: N/A
        number (not applicable)
    Notes
    [143] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [144] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [145] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [146] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Secondary: Part IB: PFS, as Determined by Investigator Using Unidimensional irRC

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    End point title
    		 Part IB: PFS, as Determined by Investigator Using Unidimensional irRC [147]
    End point description
    Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    End point type
    Secondary
    End point timeframe
    Up to 58 months
    Notes
    [147] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was specific to part 1b, therefore other arms were excluded.
    End point values
    		 Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Number of subjects analysed
    0 [148]
    0 [149]
    0 [150]
    0 [151]
    Units: N/A
        number (not applicable)
    Notes
    [148] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [149] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [150] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    [151] - Unidimensional irRC endpoints were not analyzed for this study due to early termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 58 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC)
    Reporting group description
    		 Participants received 1 mg of subcutaneous (SC) selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV)
    Reporting group description
    		 Participants received a fixed-dose of 16 mg intravenous (IV) selicrelumab in combination with 1200 mg of IV atezolizumab (ATZ).

    Reporting group title
    Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC)
    Reporting group description
    		 Participants received 16 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC)
    Reporting group description
    		 Participants received 2 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC)
    Reporting group description
    		 Participants received 32 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC)
    Reporting group description
    		 Participants received up to 9 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC)
    Reporting group description
    		 Participants received 12-21 mg of SC selicrelumab in combination with 1200 mg of ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC)
    Reporting group description
    		 Participants received 28-36 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC)
    Reporting group description
    		 Participants received 48-64 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): Small + Large Bowel Carcinoma
    Reporting group description
    		 Participants with small and large bowel carcinoma received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): NSCLC
    Reporting group description
    		 Participants with non-small cell lung cancer received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Reporting group title
    Part 2 (SC): HNSCC
    Reporting group description
    		 Participants with head and neck squamous cell carcinoma (HNSCC) received 16 mg of SC selicrelumab in combination with 1200 mg of IV ATZ.

    Serious adverse events
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC) Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): NSCLC Part 2 (SC): HNSCC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 6 (33.33%)
    1 / 8 (12.50%)
    5 / 7 (71.43%)
    1 / 4 (25.00%)
    9 / 31 (29.03%)
    5 / 16 (31.25%)
    3 / 9 (33.33%)
    4 / 9 (44.44%)
    4 / 12 (33.33%)
    6 / 14 (42.86%)
    4 / 19 (21.05%)
         number of deaths (all causes)
    5
    3
    7
    5
    2
    21
    10
    4
    5
    8
    7
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to heart
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    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
    Haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    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
    Injection site reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (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 / 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
    Hypoxia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (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
         deaths causally related 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
    Immune-mediated pneumonitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Pneumonitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Investigations
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    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
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Optic neuritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Pancytopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Urinary tract obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    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
    Bronchitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         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 / 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
    Pneumonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    2 / 14 (14.29%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 1 mg (SC) Part 1A Cohort 1: ATZ 1200 mg + Selicrelumab 16 mg (IV) Part 1A Cohort 3: ATZ 1200 mg + Selicrelumab 16 mg (SC) Part 1A Cohort 2: ATZ 1200 mg + Selicrelumab 2 mg (SC) Part 1A Cohort 4: ATZ 1200 mg + Selicrelumab 32 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 1-9 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 12-21 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 28-36 mg (SC) Part 1B: ATZ 1200 mg + Selicrelumab 48-64 mg (SC) Part 2 (SC): Small + Large Bowel Carcinoma Part 2 (SC): NSCLC Part 2 (SC): HNSCC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    5 / 6 (83.33%)
    8 / 8 (100.00%)
    7 / 7 (100.00%)
    4 / 4 (100.00%)
    31 / 31 (100.00%)
    16 / 16 (100.00%)
    9 / 9 (100.00%)
    9 / 9 (100.00%)
    12 / 12 (100.00%)
    14 / 14 (100.00%)
    19 / 19 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Cancer pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Infected neoplasm
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tumour associated fever
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Tumour pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Hot flush
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    2 / 19 (10.53%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    3
    Hypotension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Intermittent claudication
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Lymphoedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    9 / 31 (29.03%)
    5 / 16 (31.25%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    9 / 14 (64.29%)
    3 / 19 (15.79%)
         occurrences all number
    0
    0
    2
    2
    0
    14
    5
    0
    1
    1
    12
    5
    Axillary pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Catheter site inflammation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    3 / 16 (18.75%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    3 / 14 (21.43%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    4
    0
    0
    0
    3
    1
    General physical health deterioration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hernia pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperthermia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    4 / 31 (12.90%)
    2 / 16 (12.50%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    4
    0
    6
    2
    6
    0
    0
    0
    1
    Injection site inflammation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Localised oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Mucosal dryness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    Oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    1
    0
    0
    0
    3
    Swelling face
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Catheter site pruritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Chills
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    3 / 31 (9.68%)
    0 / 16 (0.00%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    0
    0
    4
    0
    2
    1
    1
    1
    1
    Cyst
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 6 (33.33%)
    2 / 8 (25.00%)
    3 / 7 (42.86%)
    2 / 4 (50.00%)
    9 / 31 (29.03%)
    3 / 16 (18.75%)
    4 / 9 (44.44%)
    7 / 9 (77.78%)
    4 / 12 (33.33%)
    1 / 14 (7.14%)
    4 / 19 (21.05%)
         occurrences all number
    4
    3
    2
    3
    2
    10
    3
    8
    11
    5
    1
    4
    Injection site atrophy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    4 / 5 (80.00%)
    0 / 6 (0.00%)
    7 / 8 (87.50%)
    7 / 7 (100.00%)
    4 / 4 (100.00%)
    28 / 31 (90.32%)
    13 / 16 (81.25%)
    8 / 9 (88.89%)
    7 / 9 (77.78%)
    11 / 12 (91.67%)
    14 / 14 (100.00%)
    17 / 19 (89.47%)
         occurrences all number
    4
    0
    7
    7
    4
    28
    14
    8
    7
    17
    28
    14
    Malaise
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    6 / 8 (75.00%)
    3 / 7 (42.86%)
    1 / 4 (25.00%)
    8 / 31 (25.81%)
    4 / 16 (25.00%)
    4 / 9 (44.44%)
    2 / 9 (22.22%)
    7 / 12 (58.33%)
    7 / 14 (50.00%)
    7 / 19 (36.84%)
         occurrences all number
    1
    1
    9
    4
    1
    12
    5
    8
    2
    9
    10
    15
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Vulvovaginal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    4 / 8 (50.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    5 / 31 (16.13%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    2 / 14 (14.29%)
    4 / 19 (21.05%)
         occurrences all number
    0
    2
    4
    2
    1
    5
    2
    0
    0
    2
    2
    4
    Dyspnoea exertional
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Hiccups
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Laryngeal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    1 / 7 (14.29%)
    2 / 4 (50.00%)
    6 / 31 (19.35%)
    0 / 16 (0.00%)
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    3 / 12 (25.00%)
    3 / 14 (21.43%)
    6 / 19 (31.58%)
         occurrences all number
    2
    0
    3
    1
    2
    6
    0
    3
    1
    3
    3
    6
    Respiratory disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    Psychiatric disorders
    Anhedonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    2
    0
    1
    2
    Anxiety disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    2 / 31 (6.45%)
    5 / 16 (31.25%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 12 (16.67%)
    2 / 14 (14.29%)
    3 / 19 (15.79%)
         occurrences all number
    2
    1
    0
    2
    1
    2
    6
    1
    1
    3
    2
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    2 / 31 (6.45%)
    6 / 16 (37.50%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 12 (25.00%)
    1 / 14 (7.14%)
    5 / 19 (26.32%)
         occurrences all number
    2
    1
    0
    2
    1
    2
    7
    1
    1
    4
    1
    8
    Blood alkaline phosphatase increase
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 14 (14.29%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    3
    2
    Blood creatinine increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 14 (14.29%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    4
    1
    0
    0
    2
    2
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    4 / 31 (12.90%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    2 / 14 (14.29%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    1
    0
    5
    2
    0
    0
    1
    4
    2
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    3 / 31 (9.68%)
    4 / 16 (25.00%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    2 / 14 (14.29%)
    3 / 19 (15.79%)
         occurrences all number
    0
    0
    0
    1
    1
    3
    4
    1
    2
    1
    2
    3
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    1
    2
    Lipase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    1
    2
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Amylase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    1
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    2
    1
    0
    0
    2
    Weight increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    1
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    Serum ferritin increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Eschar
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 6 (50.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    2 / 12 (16.67%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    5
    2
    0
    3
    2
    0
    0
    Injection related reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Pubis fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Stoma site extravasation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Stoma site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    1 / 16 (6.25%)
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    3
    1
    0
    0
    1
    Dysaesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 6 (33.33%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    3 / 16 (18.75%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    3 / 14 (21.43%)
    2 / 19 (10.53%)
         occurrences all number
    3
    2
    1
    0
    0
    3
    3
    2
    0
    2
    3
    2
    Hypoaesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Loss of consciousness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Neuralgia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    0
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    0
    3
    0
    0
    2
    1
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Taste disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    4 / 8 (50.00%)
    3 / 7 (42.86%)
    1 / 4 (25.00%)
    4 / 31 (12.90%)
    3 / 16 (18.75%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    4 / 14 (28.57%)
    7 / 19 (36.84%)
         occurrences all number
    1
    0
    4
    5
    1
    6
    5
    1
    0
    4
    4
    11
    Leukopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lymph node pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Lymphatic insufficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    4 / 31 (12.90%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    3 / 14 (21.43%)
    4 / 19 (21.05%)
         occurrences all number
    1
    1
    0
    1
    1
    4
    2
    0
    0
    0
    4
    4
    Neutropenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    2 / 14 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    3
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dry eye
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye pruritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Maculopathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    3
    1
    0
    0
    0
    0
    Xerophthalmia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    3 / 8 (37.50%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    3 / 31 (9.68%)
    3 / 16 (18.75%)
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    3
    1
    0
    6
    3
    1
    3
    1
    1
    0
    Ascites
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    8 / 31 (25.81%)
    4 / 16 (25.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    3 / 14 (21.43%)
    5 / 19 (26.32%)
         occurrences all number
    0
    1
    1
    0
    0
    9
    5
    0
    0
    2
    3
    6
    Diarrhoea
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 6 (16.67%)
    4 / 8 (50.00%)
    3 / 7 (42.86%)
    0 / 4 (0.00%)
    6 / 31 (19.35%)
    4 / 16 (25.00%)
    3 / 9 (33.33%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    2 / 19 (10.53%)
         occurrences all number
    5
    1
    4
    4
    0
    12
    8
    4
    6
    0
    1
    3
    Dyspepsia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    1 / 16 (6.25%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    2 / 14 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    2
    2
    2
    2
    1
    2
    0
    Dysphagia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Intra-abdominal fluid collection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    15 / 31 (48.39%)
    4 / 16 (25.00%)
    3 / 9 (33.33%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    5 / 14 (35.71%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    4
    1
    1
    20
    7
    8
    3
    1
    6
    2
    Pancreatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    1
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    3 / 16 (18.75%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    2 / 14 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    3
    1
    0
    0
    4
    0
    Colitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    3 / 31 (9.68%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    0
    0
    3
    0
    1
    0
    1
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
    6 / 31 (19.35%)
    3 / 16 (18.75%)
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    4 / 14 (28.57%)
    3 / 19 (15.79%)
         occurrences all number
    0
    0
    1
    2
    1
    8
    3
    7
    1
    1
    4
    3
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cholestasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Hepatic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Onychoclasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    4 / 31 (12.90%)
    1 / 16 (6.25%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    1
    2
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Erythema multiforme
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    Macule
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nail toxicity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Decubitis ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    4 / 31 (12.90%)
    5 / 16 (31.25%)
    3 / 9 (33.33%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    3 / 14 (21.43%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    2
    0
    0
    4
    5
    3
    0
    1
    4
    1
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    3 / 31 (9.68%)
    1 / 16 (6.25%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    3
    1
    2
    1
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    Skin burning sensation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Vitiligo
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Haematuria
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Urinary tract pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Cushing's syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    3 / 31 (9.68%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    3
    1
    0
    1
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    2 / 31 (6.45%)
    2 / 16 (12.50%)
    3 / 9 (33.33%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    3
    0
    1
    0
    1
    2
    2
    4
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    5 / 31 (16.13%)
    1 / 16 (6.25%)
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    2 / 14 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    7
    1
    3
    2
    1
    2
    0
    Flank pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    3 / 16 (18.75%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    3
    0
    0
    1
    0
    0
    Musculoskeletal disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    5 / 31 (16.13%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    0 / 14 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    1
    3
    0
    6
    2
    0
    0
    3
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 31 (3.23%)
    2 / 16 (12.50%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    2 / 14 (14.29%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    2
    0
    1
    0
    2
    3
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    1
    0
    3
    0
    3
    1
    0
    0
    1
    Tendon pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Orchitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    2 / 16 (12.50%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    3
    Oral candidiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Lip infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Intervertebral discitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    1
    1
    Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Eyelid infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Subcutaneous abscess
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    1
    0
    0
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    4 / 9 (44.44%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    6
    1
    1
    2
    1
    Catheter site abscess
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    3 / 14 (21.43%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    3
    0
    4
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Decreased appetite
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    5 / 31 (16.13%)
    2 / 16 (12.50%)
    4 / 9 (44.44%)
    1 / 9 (11.11%)
    2 / 12 (16.67%)
    5 / 14 (35.71%)
    3 / 19 (15.79%)
         occurrences all number
    0
    1
    2
    1
    0
    5
    2
    8
    1
    2
    6
    3
    Dehydration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gout
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    3 / 19 (15.79%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    3
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    4 / 31 (12.90%)
    0 / 16 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    0
    4
    0
    1
    0
    1
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    3 / 14 (21.43%)
    3 / 19 (15.79%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    7
    Hypernatraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hypochloraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    3 / 31 (9.68%)
    1 / 16 (6.25%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    0
    3
    1
    0
    0
    0
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    2 / 31 (6.45%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    0
    1
    0
    2
    0
    0
    0
    0
    1
    3
    Hyponatraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 31 (3.23%)
    0 / 16 (0.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    4 / 14 (28.57%)
    4 / 19 (21.05%)
         occurrences all number
    0
    2
    2
    0
    0
    1
    0
    2
    0
    0
    7
    8
    Iron deficiency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 31 (0.00%)
    0 / 16 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2015
    Clarified enrollment rules for Part IA cohort 2 and Part IB.
    21 Apr 2015
    Added a subcohort to the study.
    09 Dec 2015
    Changed selicrelumab administration to SC only; added safety run-in phase and dose escalation to Part IA; implemented additional safety measures.
    11 Dec 2016
    Modifications to selicrelumab administration routes; amended contraception requirements for male and female participants.
    06 Sep 2017
    Change to study design (merged parts II and III); updates to primary and secondary objectives.
    19 Dec 2017
    Additional safety guidelines and information; updated eligibility criteria.
    16 Nov 2018
    Update to selicrelumab route of administration in parts Ib and II; update to eligibility criteria.

    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.
    Sponsor discontinued development of selicrelumab in combination with atezolizumab due to observed limited clinical benefit. These results are abbreviated and focus on detailed safety results, limited efficacy summaries and pharmacokinetic data.
    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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