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    Clinical Trial Results:
    An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination with Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants with Advanced and/or Metastatic Solid Tumors

    Summary
    EudraCT number
    		 2017-003182-94
    Trial protocol
    		 GB   ES   BE   PL   DE   FR  
    Global end of trial date
    30 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jan 2023
    First version publication date
    08 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BP40234
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03386721
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 +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
    30 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. The main focus of this study was on participants with non−small cell lung cancer (NCSLC) and participants with squamous cell carcinoma (SCC) of the Head and Neck (HNSCC), esophagus (ESCC) and cervix (CSCC).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 2018
    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
    Belgium: 18
    Country: Number of subjects enrolled
    France: 29
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Israel: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 19
    Country: Number of subjects enrolled
    New Zealand: 8
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Russian Federation: 4
    Country: Number of subjects enrolled
    Singapore: 7
    Country: Number of subjects enrolled
    Spain: 78
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Taiwan: 10
    Country: Number of subjects enrolled
    Turkey: 36
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    256
    EEA total number of subjects
    145
    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)
    182
    From 65 to 84 years
    74
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants took part in the study at 42 investigative sites in Belgium, France, Germany, Israel, Korea, New Zealand, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, USA from 19 February 2018 to 30 December 2021.

    Pre-assignment
    Screening details
    		 A total of 256 participants were enrolled. 95 in NCSLC cohorts [Part I: A,B,D,F&Part II: E]; 161 in SCC cohorts (78 in HNSCC [Part III:G,H,K], 35 in ESCC [Part 3: I&M], & 48 in CSCC [Part III:J&N]) received simlukafusp alfa & atezolizumab.No participants were enrolled in Cohorts C&L as emerging data didn't lead to the need to open these cohorts.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NSCLC: Part I Cohort A (QW/Q2W)
    Arm description
    		 Checkpoint Inhibitor (CPI)-naïve participants with NSCLC, received simlukafusp alfa, 10 milligrams (mg), intravenous (IV) infusion, once weekly (QW) for the first 4 weeks, and every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 840 mg, IV infusion, Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, QW for first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.

    Arm title
    		 NSCLC: Part I Cohort B (QW/Q2W)
    Arm description
    		 CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 840 mg, IV infusion, Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, QW for first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.

    Arm title
    		 NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
    Arm description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 840 mg, IV infusion, Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, QW for first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.

    Arm title
    		 NSCLC: Part I Cohort D, Arm 2 (Q3W)
    Arm description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion once in 3 weeks (Q3W) in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.

    Arm title
    		 NSCLC: Part I Cohort D, Arm 3 (Q3W)
    Arm description
    		 CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine, IV infusion administered as per approved protocol.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.

    Arm title
    		 NSCLC: Part I Cohort F (Q3W)
    Arm description
    		 CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.

    Arm title
    		 NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
    Arm description
    		 NSCLC participants without prior treatment for metastatic disease and with high programmed death-ligand 1 (PD-L1) expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 840 mg, IV infusion, Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, QW for first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.

    Arm title
    		 NSCLC: Part II Cohort E, Arm 2 (Q3W)
    Arm description
    		 NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.

    Arm title
    		 SCCHN: Part III Cohort G (Q3W)
    Arm description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.

    Arm title
    		 SCCHN: Part III Cohort H (Q3W)
    Arm description
    		 CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.

    Arm title
    		 ESCC: Part III Cohort I (Q3W)
    Arm description
    		 CPI-naïve participants with ESCC who were previously treated with standard therapy received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.

    Arm title
    		 CSCC: Part III Cohort J (Q3W)
    Arm description
    		 CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.

    Arm title
    		 SCCHN: Part III Cohort K (QW/Q2W)
    Arm description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 840 mg, IV infusion, Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion, Solution for infusion
    Routes of administration
    Intravenous use, Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, QW for first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months

    Arm title
    		 ESCC: Part III Cohort M (QW/Q2W)
    Arm description
    		 Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion, Solution for infusion
    Routes of administration
    Intravenous use, Intravenous use
    Dosage and administration details
    Atezolizumab, 840 mg, IV infusion, Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, QW for first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months

    Arm title
    		 CSCC: Part III Cohort N (QW/Q2W)
    Arm description
    		 Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 840 mg, IV infusion, Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.

    Investigational medicinal product name
    Simlukafusp alfa
    Investigational medicinal product code
    RO6874281
    Other name
    FAP-IL2v active
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Simlukafusp alfa, 10 mg, IV infusion, QW for first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months

    Number of subjects in period 1
    		NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Started
    26
    32
    3
    5
    2
    22
    3
    2
    23
    30
    33
    47
    25
    2
    1
    Completed
    4
    1
    0
    0
    0
    1
    0
    0
    1
    0
    2
    6
    0
    0
    0
    Not completed
    22
    31
    3
    5
    2
    21
    3
    2
    22
    30
    31
    41
    25
    2
    1
         Consent withdrawn by subject
    1
    2
    -
    -
    -
    -
    -
    -
    2
    1
    3
    2
    3
    -
    -
         Death
    12
    21
    2
    5
    1
    12
    1
    1
    12
    20
    21
    21
    14
    2
    1
         Progressive Disease
    -
    -
    1
    -
    -
    1
    -
    -
    2
    1
    1
    -
    1
    -
    -
         Site Terminated by Sponsor
    5
    5
    -
    -
    1
    3
    -
    1
    4
    5
    3
    11
    6
    -
    -
         Symptomatic Deterioration
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    1
    3
    -
    -
    -
    2
    1
    -
    1
    2
    1
    -
    -
    -
    -
         Reason not specified
    3
    -
    -
    -
    -
    3
    1
    -
    -
    1
    2
    6
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NSCLC: Part I Cohort A (QW/Q2W)
    Reporting group description
    		 Checkpoint Inhibitor (CPI)-naïve participants with NSCLC, received simlukafusp alfa, 10 milligrams (mg), intravenous (IV) infusion, once weekly (QW) for the first 4 weeks, and every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.

    Reporting group title
    NSCLC: Part I Cohort B (QW/Q2W)
    Reporting group description
    		 CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
    Reporting group description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 2 (Q3W)
    Reporting group description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion once in 3 weeks (Q3W) in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 3 (Q3W)
    Reporting group description
    		 CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.

    Reporting group title
    NSCLC: Part I Cohort F (Q3W)
    Reporting group description
    		 CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.

    Reporting group title
    NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
    Reporting group description
    		 NSCLC participants without prior treatment for metastatic disease and with high programmed death-ligand 1 (PD-L1) expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.

    Reporting group title
    NSCLC: Part II Cohort E, Arm 2 (Q3W)
    Reporting group description
    		 NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.

    Reporting group title
    SCCHN: Part III Cohort G (Q3W)
    Reporting group description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.

    Reporting group title
    SCCHN: Part III Cohort H (Q3W)
    Reporting group description
    		 CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.

    Reporting group title
    ESCC: Part III Cohort I (Q3W)
    Reporting group description
    		 CPI-naïve participants with ESCC who were previously treated with standard therapy received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.

    Reporting group title
    CSCC: Part III Cohort J (Q3W)
    Reporting group description
    		 CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.

    Reporting group title
    SCCHN: Part III Cohort K (QW/Q2W)
    Reporting group description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.

    Reporting group title
    ESCC: Part III Cohort M (QW/Q2W)
    Reporting group description
    		 Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.

    Reporting group title
    CSCC: Part III Cohort N (QW/Q2W)
    Reporting group description
    		 Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.

    Reporting group values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W) Total
    Number of subjects
    		 26 32 3 5 2 22 3 2 23 30 33 47 25 2 1 256
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.0 ( 10.5 ) 59.8 ( 9.9 ) 63.7 ( 3.8 ) 65.6 ( 4.3 ) 63.5 ( 4.9 ) 57.4 ( 8.9 ) 56.7 ( 0.6 ) 68.0 ( 2.8 ) 55.7 ( 12.8 ) 58.8 ( 8.2 ) 63.1 ( 9.6 ) 51.3 ( 11.2 ) 55.8 ( 11.7 ) 67.0 ( 15.6 ) 49.0 ( 99999 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 10 10 1 0 1 11 1 0 5 7 10 47 6 0 1 110
        Male
    		 16 22 2 5 1 11 2 2 18 23 23 0 19 2 0 146
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 0 0 1 0 0 0 1 0 0 0 0 0 3
        Not Hispanic or Latino
    		 23 28 3 4 2 20 3 2 22 21 27 33 23 1 1 213
        Not Stated
    		 1 2 0 1 0 1 0 0 1 7 4 9 2 1 0 29
        Unknown
    		 2 1 0 0 0 0 0 0 0 1 2 5 0 0 0 11
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Asian
    		 9 5 0 0 0 5 1 0 3 5 6 0 5 1 0 40
        Native Hawaiian or Other Pacific Islander
    		 2 0 0 0 0 0 0 0 1 0 0 1 0 0 0 4
        Black or African American
    		 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 2
        White
    		 15 26 3 5 2 17 2 2 19 16 22 33 18 0 1 181
        More than one race
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0 0 0 0 8 5 13 2 1 0 29

    End points

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    End points reporting groups
    Reporting group title
    NSCLC: Part I Cohort A (QW/Q2W)
    Reporting group description
    		 Checkpoint Inhibitor (CPI)-naïve participants with NSCLC, received simlukafusp alfa, 10 milligrams (mg), intravenous (IV) infusion, once weekly (QW) for the first 4 weeks, and every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.

    Reporting group title
    NSCLC: Part I Cohort B (QW/Q2W)
    Reporting group description
    		 CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
    Reporting group description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 2 (Q3W)
    Reporting group description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion once in 3 weeks (Q3W) in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 3 (Q3W)
    Reporting group description
    		 CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.

    Reporting group title
    NSCLC: Part I Cohort F (Q3W)
    Reporting group description
    		 CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.

    Reporting group title
    NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
    Reporting group description
    		 NSCLC participants without prior treatment for metastatic disease and with high programmed death-ligand 1 (PD-L1) expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.

    Reporting group title
    NSCLC: Part II Cohort E, Arm 2 (Q3W)
    Reporting group description
    		 NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.

    Reporting group title
    SCCHN: Part III Cohort G (Q3W)
    Reporting group description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.

    Reporting group title
    SCCHN: Part III Cohort H (Q3W)
    Reporting group description
    		 CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.

    Reporting group title
    ESCC: Part III Cohort I (Q3W)
    Reporting group description
    		 CPI-naïve participants with ESCC who were previously treated with standard therapy received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.

    Reporting group title
    CSCC: Part III Cohort J (Q3W)
    Reporting group description
    		 CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.

    Reporting group title
    SCCHN: Part III Cohort K (QW/Q2W)
    Reporting group description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.

    Reporting group title
    ESCC: Part III Cohort M (QW/Q2W)
    Reporting group description
    		 Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.

    Reporting group title
    CSCC: Part III Cohort N (QW/Q2W)
    Reporting group description
    		 Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.

    Primary: Percentage of Participants with Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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    End point title
    		 Percentage of Participants with Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [1]
    End point description
    ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point. Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
    End point type
    Primary
    End point timeframe
    Baseline up to disease progression or study treatment discontinuation (up to 38 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: As pre specified in the protocol no formal statistical model and no formal hypothesis testing were planned in this for this endpoint.
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    26
    32
    3
    5
    0 [2]
    21
    3
    2
    22
    28
    32
    44
    25
    2
    1
    Units: percentage of participants
        number (confidence interval 95%)
    19.2 (8.51 to 37.88)
    6.3 (1.73 to 20.15)
    0 (0.00 to 56.15)
    0 (0.00 to 43.45)
    ( to )
    4.8 (0.85 to 22.67)
    66.7 (20.77 to 93.85)
    50.0 (9.45 to 90.55)
    18.2 (7.31 to 38.52)
    3.6 (0.63 to 17.71)
    21.9 (11.02 to 38.75)
    27.3 (16.35 to 41.85)
    4.0 (0.71 to 19.54)
    0 (0.00 to 65.76)
    0 (0.00 to 79.35)
    Notes
    [2] - Participants from this cohort were not included in the Response evaluable population.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Disease Control Rate (DCR) Determined According to RECIST Version 1.1

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    End point title
    		 Percentage of Participants with Disease Control Rate (DCR) Determined According to RECIST Version 1.1
    End point description
    DCR: percentage of participants with observed tumor response of CR, PR or stable disease (SD) as per RECIST v 1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 mm. PR = at least a 30% decrease in the sum of diameters of target lesions, with reference to baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD = at least a 20% decrease in the sum of diameters of target lesions, with reference to smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point. Response evaluable population = all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
    End point type
    Secondary
    End point timeframe
    Baseline up to disease progression or study treatment discontinuation (up to 38 months)
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    26
    32
    3
    5
    0 [3]
    21
    3
    2
    22
    28
    32
    44
    25
    2
    1
    Units: percentage of participants
        number (confidence interval 95%)
    53.8 (35.46 to 71.24)
    62.5 (45.25 to 77.07)
    0 (0.00 to 56.15)
    20.0 (3.62 to 62.45)
    ( to )
    57.1 (36.55 to 75.53)
    66.7 (20.77 to 93.85)
    50.0 (9.45 to 90.55)
    50.0 (30.72 to 69.28)
    14.3 (5.70 to 31.49)
    43.8 (28.17 to 60.67)
    68.2 (53.44 to 80.00)
    36.0 (20.25 to 55.48)
    50.0 (9.45 to 90.55)
    0 (0.00 to 79.35)
    Notes
    [3] - Participants form this cohort were not included in the Response evaluable population
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR) According to RECIST Version 1.1

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    End point title
    		 Duration of Response (DoR) According to RECIST Version 1.1
    End point description
    DoR was determined for participants who had a best overall response of CR or PR. CR = disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR = time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment. Data could not be collected for this endpoint due to premature termination of the study by the sponsor.
    End point type
    Secondary
    End point timeframe
    From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [4] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [5] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [6] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [7] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [8] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [9] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [10] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [11] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [12] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [13] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [14] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [15] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [16] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [17] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    [18] - Data was not collected for this endpoint due to premature termination of the study by the sponsor.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) According to RECIST Version 1.1

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    End point title
    		 Progression-Free Survival (PFS) According to RECIST Version 1.1
    End point description
    PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 [1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts]) to the first occurrence of documented disease progression (based on Investigator’s assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment. Here, 99999=Medain and upper limit of 95% CI could not be calculated due to low number of participants with events. 0.99999=Lower limit of 95% CI could not be calculated as only one participant with events was evaluated. 999999=Upper limit of 95% CI could not be calculated as only one participant with events was evaluated. Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment.
    End point type
    Secondary
    End point timeframe
    Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    26
    32
    3
    5
    0 [19]
    21
    3
    2
    22
    28
    32
    44
    25
    2
    1
    Units: months
        median (confidence interval 95%)
    3.5 (1.7 to 7.4)
    3.7 (3.1 to 5.2)
    2.0 (1.7 to 99999)
    2.0 (1.9 to 99999)
    ( to )
    3.5 (1.9 to 5.5)
    99999 (2.6 to 99999)
    10.5 (1.9 to 99999)
    2.5 (1.8 to 5.6)
    1.9 (1.8 to 1.9)
    1.9 (1.8 to 3.7)
    3.7 (3.3 to 9.0)
    1.9 (1.6 to 3.2)
    2.6 (1.6 to 99999)
    1.9 (0.99999 to 999999)
    Notes
    [19] - Participants from this cohort were not included in the Response evaluable population.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive. As pre-specified in the protocol, data for OS was to be reported if data was mature at the time of analysis. The data was not reported for this endpoint as data was not matured and sufficient to be analysed during the analysis as the study was terminated prematurely and no safety follow for survival took place.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment up to death due to any cause (up to approximately 47 months)
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [20] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [21] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [22] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [23] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [24] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [25] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [26] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [27] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [28] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [29] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [30] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [31] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [32] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [33] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    [34] - Data is not reported for this endpoint as data was not matured & sufficient to be analysed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events (AEs)

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    End point title
    		 Percentage of Participants with Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Safety Population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
    End point type
    Secondary
    End point timeframe
    Baseline up to end of the study (up to approximately 47 months)
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    26
    32
    3
    5
    2
    22
    3
    2
    23
    30
    33
    47
    25
    2
    1
    Units: percentage of participants
        number (not applicable)
    100
    100
    100
    100
    100
    100
    100
    100
    100
    100
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods

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    End point title
    		 Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods
    End point description
    Data was not collected for this endpoint post-baseline as baseline data was not matured and sufficient to analyse PD-L1 impact.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    0 [42]
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    Units: percentage of participants
    Notes
    [35] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [36] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [37] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [38] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [39] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [40] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [41] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [42] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [43] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [44] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [45] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [46] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [47] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [48] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [49] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods

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    End point title
    		 Change from Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods
    End point description
    Data was not collected for this endpoint post-baseline as baseline data was not matured and sufficient to be analysed during analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to 2 months
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    0 [50]
    0 [51]
    0 [52]
    0 [53]
    0 [54]
    0 [55]
    0 [56]
    0 [57]
    0 [58]
    0 [59]
    0 [60]
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    Units: Cell/mm (2)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [50] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [51] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [52] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [53] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [54] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [55] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [56] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [57] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [58] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [59] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [60] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [61] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [62] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [63] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [64] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods

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    End point title
    		 Change from Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods
    End point description
    Data was not collected for this endpoint post-baseline as baseline data was not matured and sufficient to be analysed during analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to 2 months
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    0 [65]
    0 [66]
    0 [67]
    0 [68]
    0 [69]
    0 [70]
    0 [71]
    0 [72]
    0 [73]
    0 [74]
    0 [75]
    0 [76]
    0 [77]
    0 [78]
    0 [79]
    Units: Cell/mm (2)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [65] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [66] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [67] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [68] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [69] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [70] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [71] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [72] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [73] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [74] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [75] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [76] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [77] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [78] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    [79] - Data was not reported as data was not matured and sufficient to be analysed during analysis.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Density of PD-L1 According to Immunohistochemical Methods

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    End point title
    		 Change from Baseline in Density of PD-L1 According to Immunohistochemical Methods
    End point description
    Data was not collected for this endpoint post-baseline as baseline data was not matured and sufficient to analyse PD-L1 impact.
    End point type
    Secondary
    End point timeframe
    Baseline up to 2 months
    End point values
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort I (Q3W) CSCC: Part III Cohort J (Q3W) SCCHN: Part III Cohort K (QW/Q2W) ESCC: Part III Cohort M (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Number of subjects analysed
    0 [80]
    0 [81]
    0 [82]
    0 [83]
    0 [84]
    0 [85]
    0 [86]
    0 [87]
    0 [88]
    0 [89]
    0 [90]
    0 [91]
    0 [92]
    0 [93]
    0 [94]
    Units: Cell/mm (2)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [80] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [81] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [82] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [83] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [84] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [85] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [86] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [87] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [88] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [89] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [90] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [91] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [92] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [93] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    [94] - Data was not reported as data was not matured and sufficient to analyse PD-L1 impact.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to end of the study (up to approximately 47 months)
    Adverse event reporting additional description
    Safety-evaluable population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    NSCLC: Part I Cohort A (QW/Q2W)
    Reporting group description
    		 CPI-naïve participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 38 months.

    Reporting group title
    NSCLC: Part I Cohort B (QW/Q2W)
    Reporting group description
    		 CPI-experienced participants with NSCLC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 15.6 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)
    Reporting group description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 2.7 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 2 (Q3W)
    Reporting group description
    		 CPI-experienced participants with NSCLC previously treated with platinum-containing regimen and docetaxel received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 5.4 months.

    Reporting group title
    NSCLC: Part I Cohort D, Arm 3 (Q3W)
    Reporting group description
    		 CPI-experienced participants with NSCLC who were previously treated with platinum-containing regimen and docetaxel received a gemcitabine, IV infusion as per approved protocol. Participants who had documented radiographic disease progression during or after treatment with gemcitabine received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 1.3 months.

    Reporting group title
    NSCLC: Part I Cohort F (Q3W)
    Reporting group description
    		 CPI-experienced, docetaxel naive participants with NSCLC who experienced disease progression during or after treatment with a platinum-containing regimen received, simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 26 months.

    Reporting group title
    NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)
    Reporting group description
    		 NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 31.3 months.

    Reporting group title
    NSCLC: Part II Cohort E, Arm 2 (Q3W)
    Reporting group description
    		 NSCLC participants without prior treatment for metastatic disease and with high PD-L1 expression levels, received simlukafusp alfa, 10 mg, IV infusion Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 18.6 months.

    Reporting group title
    CSCC: Part III Cohort J (Q3W)
    Reporting group description
    		 CPI-naïve participants with CSCC who were previously treated with standard therapy, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 28.8 months.

    Reporting group title
    ESCC: Part III Cohort I (Q3W)
    Reporting group description
    		 CPI-naïve participants with ESCC who were previously treated with standard therapy received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 30.5 months.

    Reporting group title
    SCCHN: Part III Cohort G (Q3W)
    Reporting group description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.6 months.

    Reporting group title
    SCCHN: Part III Cohort H (Q3W)
    Reporting group description
    		 CPI-experienced participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, Q3W in combination with atezolizumab, 1200 mg, IV infusion, Q3W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 10.3 months.

    Reporting group title
    ESCC: Part III Cohort M (QW/Q2W)
    Reporting group description
    		 Participants with ESCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 4.1 months.

    Reporting group title
    SCCHN: Part III Cohort K (QW/Q2W)
    Reporting group description
    		 CPI-naïve participants with SCCHN, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 24.3 months.

    Reporting group title
    CSCC: Part III Cohort N (QW/Q2W)
    Reporting group description
    		 Participants with CSCC, received simlukafusp alfa, 10 mg, IV infusion, QW for the first 4 weeks, and Q2W until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months. Participants also received atezolizumab, 840 mg, IV infusion, Q2W in combination with simlukafusp alfa until disease progression, unacceptable toxicity, or withdrawal of consent, or for a maximum of 0.68 months.

    Serious adverse events
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) CSCC: Part III Cohort J (Q3W) ESCC: Part III Cohort I (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort M (QW/Q2W) SCCHN: Part III Cohort K (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 26 (50.00%)
    25 / 32 (78.13%)
    0 / 3 (0.00%)
    3 / 5 (60.00%)
    2 / 2 (100.00%)
    14 / 22 (63.64%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    32 / 47 (68.09%)
    20 / 33 (60.61%)
    15 / 23 (65.22%)
    22 / 30 (73.33%)
    1 / 2 (50.00%)
    14 / 25 (56.00%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    12
    21
    3
    5
    1
    12
    1
    1
    21
    21
    14
    20
    2
    14
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    MALIGNANT NEOPLASM PROGRESSION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TUMOUR HAEMORRHAGE
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    TUMOUR PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    CAPILLARY LEAK SYNDROME
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EMBOLISM
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOTENSION
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VASCULITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    MEDICAL DEVICE REMOVAL
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHILLS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FACIAL PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FATIGUE
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GENERALISED OEDEMA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFLAMMATION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MALAISE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MEDICAL DEVICE SITE HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OEDEMA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PAIN
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PERFORMANCE STATUS DECREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    1 / 26 (3.85%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    3 / 30 (10.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    5 / 6
    2 / 2
    0 / 0
    4 / 4
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    ANAPHYLACTIC REACTION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ANAPHYLACTIC SHOCK
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SYSTEMIC IMMUNE ACTIVATION
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    FEMALE GENITAL TRACT FISTULA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASPIRATION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ASTHMA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BRONCHOSPASM
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COUGH
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HAEMOPTYSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    LARYNGEAL HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PHARYNGEAL HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMOTHORAX
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    CONFUSIONAL STATE
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    DEVICE DISLOCATION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EJECTION FRACTION DECREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LIVER FUNCTION TEST INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    5 / 5
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OXYGEN SATURATION DECREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (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
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSAMINASES INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    INCORRECT DOSE ADMINISTERED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 / 26 (0.00%)
    3 / 32 (9.38%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    7 / 47 (14.89%)
    1 / 33 (3.03%)
    2 / 23 (8.70%)
    3 / 30 (10.00%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    17 / 17
    0 / 0
    4 / 4
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    12 / 12
    1 / 1
    2 / 2
    3 / 3
    0 / 0
    9 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MEDICATION ERROR
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SKIN LACERATION
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UROSTOMY COMPLICATION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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 ACCESS COMPLICATION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    TRACHEO-OESOPHAGEAL FISTULA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MYOCARDITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PERICARDIAL EFFUSION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TACHYCARDIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    AGNOSIA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    APHASIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIZZINESS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ENCEPHALOPATHY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NEURALGIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    POLYNEUROPATHY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VOCAL CORD PARALYSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 3
    0 / 0
    1 / 1
    2 / 3
    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
    0 / 0
    0 / 0
    0 / 0
    LYMPHOPENIA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    4 / 4
    0 / 0
    3 / 3
    2 / 2
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COLITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GASTRIC HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    IMMUNE-MEDIATED ENTEROCOLITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LARGE INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MOUTH HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NAUSEA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OESOPHAGEAL FISTULA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OESOPHAGEAL OBSTRUCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OESOPHAGEAL STENOSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PANCREATITIS ACUTE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PROCTALGIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UPPER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    BILE DUCT STENOSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BILIARY OBSTRUCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CHOLECYSTITIS ACUTE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DRUG-INDUCED LIVER INJURY
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HEPATITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HEPATOTOXICITY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PRURITUS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RASH
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    STEVENS-JOHNSON SYNDROME
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    2 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HAEMATURIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYDRONEPHROSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NEPHRITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYELOCALIECTASIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RENAL FAILURE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT OBSTRUCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    ADDISON'S DISEASE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    IMMUNE-MEDIATED HYPOPHYSITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MYALGIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PATHOLOGICAL FRACTURE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ABDOMINAL WALL ABSCESS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ARTHRITIS BACTERIAL
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ASPERGILLUS INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    BACTERIAL INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CORNEAL INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ENCEPHALITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ESCHERICHIA INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LYMPH GLAND INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PELVIC INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PERITONEAL ABSCESS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PLEURAL INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 32 (9.38%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    2 / 23 (8.70%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    PNEUMONIA BACTERIAL
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    1 / 2 (50.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA NECROTISING
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PULMONARY SEPSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SKIN INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VASCULAR DEVICE INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPERCALCAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    2 / 23 (8.70%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPERKALAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOALBUMINAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOGLYCAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    2 / 23 (8.70%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MALNUTRITION
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TYPE 1 DIABETES MELLITUS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (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
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 NSCLC: Part I Cohort A (QW/Q2W) NSCLC: Part I Cohort B (QW/Q2W) NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) NSCLC: Part I Cohort D, Arm 2 (Q3W) NSCLC: Part I Cohort D, Arm 3 (Q3W) NSCLC: Part I Cohort F (Q3W) NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) NSCLC: Part II Cohort E, Arm 2 (Q3W) CSCC: Part III Cohort J (Q3W) ESCC: Part III Cohort I (Q3W) SCCHN: Part III Cohort G (Q3W) SCCHN: Part III Cohort H (Q3W) ESCC: Part III Cohort M (QW/Q2W) SCCHN: Part III Cohort K (QW/Q2W) CSCC: Part III Cohort N (QW/Q2W)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 26 (96.15%)
    32 / 32 (100.00%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    2 / 2 (100.00%)
    21 / 22 (95.45%)
    3 / 3 (100.00%)
    2 / 2 (100.00%)
    47 / 47 (100.00%)
    33 / 33 (100.00%)
    23 / 23 (100.00%)
    29 / 30 (96.67%)
    2 / 2 (100.00%)
    24 / 25 (96.00%)
    1 / 1 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    TUMOUR PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Vascular disorders
    CAPILLARY LEAK SYNDROME
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    HOT FLUSH
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    HYPERTENSION
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    1 / 2 (50.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    1
    2
    2
    1
    1
    1
    4
    0
    HYPOTENSION
         subjects affected / exposed
    2 / 26 (7.69%)
    11 / 32 (34.38%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    6 / 22 (27.27%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    2 / 33 (6.06%)
    4 / 23 (17.39%)
    8 / 30 (26.67%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    14
    0
    0
    0
    6
    0
    0
    8
    3
    5
    11
    0
    3
    0
    THROMBOSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    6 / 26 (23.08%)
    7 / 32 (21.88%)
    2 / 3 (66.67%)
    2 / 5 (40.00%)
    1 / 2 (50.00%)
    7 / 22 (31.82%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    23 / 47 (48.94%)
    8 / 33 (24.24%)
    9 / 23 (39.13%)
    12 / 30 (40.00%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    8
    3
    2
    1
    8
    2
    0
    28
    8
    10
    12
    0
    4
    0
    CHEST PAIN
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    3 / 33 (9.09%)
    0 / 23 (0.00%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    2
    3
    0
    2
    0
    1
    0
    CHILLS
         subjects affected / exposed
    12 / 26 (46.15%)
    12 / 32 (37.50%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    0 / 2 (0.00%)
    9 / 22 (40.91%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    12 / 47 (25.53%)
    12 / 33 (36.36%)
    6 / 23 (26.09%)
    10 / 30 (33.33%)
    2 / 2 (100.00%)
    9 / 25 (36.00%)
    1 / 1 (100.00%)
         occurrences all number
    23
    23
    1
    4
    0
    15
    3
    0
    18
    25
    8
    10
    7
    49
    3
    FATIGUE
         subjects affected / exposed
    14 / 26 (53.85%)
    15 / 32 (46.88%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    9 / 47 (19.15%)
    8 / 33 (24.24%)
    6 / 23 (26.09%)
    5 / 30 (16.67%)
    0 / 2 (0.00%)
    11 / 25 (44.00%)
    1 / 1 (100.00%)
         occurrences all number
    25
    21
    0
    1
    0
    6
    4
    1
    12
    11
    9
    6
    0
    19
    1
    HYPERTHERMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    23
    0
    0
    0
    0
    0
    0
    MALAISE
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    1
    0
    1
    0
    0
    0
    5
    0
    3
    2
    0
    0
    0
    OEDEMA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    6 / 26 (23.08%)
    4 / 32 (12.50%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    7 / 47 (14.89%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    7
    1
    1
    0
    1
    0
    0
    9
    2
    1
    2
    0
    0
    0
    PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    1
    0
    PYREXIA
         subjects affected / exposed
    20 / 26 (76.92%)
    29 / 32 (90.63%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    1 / 2 (50.00%)
    15 / 22 (68.18%)
    2 / 3 (66.67%)
    1 / 2 (50.00%)
    35 / 47 (74.47%)
    26 / 33 (78.79%)
    18 / 23 (78.26%)
    22 / 30 (73.33%)
    2 / 2 (100.00%)
    21 / 25 (84.00%)
    1 / 1 (100.00%)
         occurrences all number
    197
    91
    11
    11
    3
    47
    7
    3
    134
    116
    76
    60
    13
    110
    4
    XEROSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    7
    5
    1
    0
    0
    0
    0
    COUGH
         subjects affected / exposed
    4 / 26 (15.38%)
    8 / 32 (25.00%)
    2 / 3 (66.67%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    4 / 22 (18.18%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    4 / 33 (12.12%)
    2 / 23 (8.70%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    11
    2
    0
    1
    4
    1
    0
    6
    5
    2
    1
    0
    2
    0
    DYSPHONIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    3 / 23 (13.04%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    4
    0
    0
    1
    0
    DYSPNOEA
         subjects affected / exposed
    6 / 26 (23.08%)
    7 / 32 (21.88%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    3 / 22 (13.64%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    4 / 33 (12.12%)
    2 / 23 (8.70%)
    3 / 30 (10.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    8
    10
    1
    0
    1
    3
    1
    0
    8
    5
    2
    3
    0
    3
    0
    HAEMOPTYSIS
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    4
    0
    0
    0
    NASAL CONGESTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 26 (7.69%)
    3 / 32 (9.38%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    2
    0
    PNEUMONITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    2
    0
    0
    0
    2
    0
    PRODUCTIVE COUGH
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    3 / 33 (9.09%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    2
    0
    1
    0
    0
    1
    0
    3
    3
    1
    1
    0
    0
    0
    RHINORRHOEA
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    1
    0
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    5 / 47 (10.64%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    5
    2
    1
    1
    0
    1
    0
    CONFUSIONAL STATE
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    1
    0
    INSOMNIA
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 2 (50.00%)
    3 / 22 (13.64%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    8 / 47 (17.02%)
    3 / 33 (9.09%)
    3 / 23 (13.04%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    1
    0
    1
    1
    3
    0
    0
    9
    5
    3
    0
    0
    1
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    9 / 26 (34.62%)
    9 / 32 (28.13%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    21 / 47 (44.68%)
    14 / 33 (42.42%)
    12 / 23 (52.17%)
    6 / 30 (20.00%)
    0 / 2 (0.00%)
    9 / 25 (36.00%)
    0 / 1 (0.00%)
         occurrences all number
    24
    12
    0
    1
    0
    7
    1
    1
    49
    27
    21
    7
    0
    13
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    12 / 26 (46.15%)
    8 / 32 (25.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    5 / 22 (22.73%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    22 / 47 (46.81%)
    14 / 33 (42.42%)
    16 / 23 (69.57%)
    6 / 30 (20.00%)
    1 / 2 (50.00%)
    11 / 25 (44.00%)
    0 / 1 (0.00%)
         occurrences all number
    27
    13
    0
    1
    0
    9
    1
    1
    56
    25
    37
    9
    1
    21
    0
    BILIRUBIN CONJUGATED INCREASED
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    3
    1
    1
    0
    0
    0
    0
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    11 / 47 (23.40%)
    5 / 33 (15.15%)
    7 / 23 (30.43%)
    4 / 30 (13.33%)
    0 / 2 (0.00%)
    8 / 25 (32.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    4
    0
    0
    0
    2
    0
    0
    18
    7
    15
    5
    0
    15
    0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    6 / 26 (23.08%)
    6 / 32 (18.75%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    3 / 3 (100.00%)
    0 / 2 (0.00%)
    12 / 47 (25.53%)
    6 / 33 (18.18%)
    5 / 23 (21.74%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    6 / 25 (24.00%)
    0 / 1 (0.00%)
         occurrences all number
    15
    11
    0
    0
    0
    1
    10
    0
    14
    7
    10
    4
    0
    6
    0
    BLOOD CHOLESTEROL INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    3 / 26 (11.54%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    1 / 33 (3.03%)
    4 / 23 (17.39%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    7
    0
    0
    0
    0
    0
    0
    7
    1
    8
    3
    0
    3
    0
    BLOOD LACTATE DEHYDROGENASE INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    8
    5
    1
    0
    0
    6
    0
    BLOOD URIC ACID INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    0
    0
    0
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    2
    0
    EOSINOPHIL COUNT INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    5 / 26 (19.23%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    16 / 47 (34.04%)
    5 / 33 (15.15%)
    12 / 23 (52.17%)
    9 / 30 (30.00%)
    0 / 2 (0.00%)
    12 / 25 (48.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    9
    0
    0
    0
    3
    4
    0
    25
    7
    28
    9
    0
    17
    0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    1
    0
    0
    0
    LIPASE INCREASED
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 32 (9.38%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    5 / 47 (10.64%)
    3 / 33 (9.09%)
    3 / 23 (13.04%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    8
    6
    0
    4
    0
    0
    0
    0
    9
    9
    10
    0
    0
    16
    0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    5
    0
    3
    0
    0
    0
    0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    5 / 47 (10.64%)
    2 / 33 (6.06%)
    6 / 23 (26.09%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    1
    0
    7
    6
    24
    2
    0
    8
    0
    TRANSAMINASES INCREASED
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    8
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    1
    0
    1
    0
    WEIGHT DECREASED
         subjects affected / exposed
    6 / 26 (23.08%)
    0 / 32 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    2 / 33 (6.06%)
    2 / 23 (8.70%)
    3 / 30 (10.00%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    7
    0
    1
    0
    0
    1
    0
    0
    2
    2
    2
    3
    0
    3
    0
    WEIGHT INCREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    4 / 23 (17.39%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    10
    0
    0
    9
    0
    Injury, poisoning and procedural complications
    INFUSION RELATED REACTION
         subjects affected / exposed
    4 / 26 (15.38%)
    7 / 32 (21.88%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    7 / 47 (14.89%)
    5 / 33 (15.15%)
    2 / 23 (8.70%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    5 / 25 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    11
    16
    0
    2
    0
    4
    1
    0
    16
    23
    13
    3
    0
    24
    0
    TOOTH FRACTURE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    CARDIAC FAILURE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    0 / 26 (0.00%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    3 / 33 (9.09%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    1
    0
    5
    3
    1
    2
    0
    1
    0
    DYSGEUSIA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    HEADACHE
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    2 / 3 (66.67%)
    0 / 2 (0.00%)
    8 / 47 (17.02%)
    7 / 33 (21.21%)
    2 / 23 (8.70%)
    1 / 30 (3.33%)
    1 / 2 (50.00%)
    4 / 25 (16.00%)
    1 / 1 (100.00%)
         occurrences all number
    8
    6
    0
    1
    2
    0
    3
    0
    9
    13
    3
    1
    1
    10
    1
    HYPOAESTHESIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    1 / 33 (3.03%)
    2 / 23 (8.70%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    3
    1
    3
    0
    0
    0
    0
    NEUROTOXICITY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PRESYNCOPE
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    3 / 30 (10.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    0
    SYNCOPE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    3 / 26 (11.54%)
    11 / 32 (34.38%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    5 / 22 (22.73%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    23 / 47 (48.94%)
    7 / 33 (21.21%)
    15 / 23 (65.22%)
    9 / 30 (30.00%)
    0 / 2 (0.00%)
    11 / 25 (44.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    18
    0
    3
    0
    7
    0
    0
    40
    8
    29
    13
    0
    29
    0
    COAGULOPATHY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    4
    0
    0
    0
    LEUKOPENIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    11
    2
    1
    0
    0
    2
    0
    LYMPHOCYTOSIS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    LYMPHOPENIA
         subjects affected / exposed
    0 / 26 (0.00%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    3 / 33 (9.09%)
    4 / 23 (17.39%)
    3 / 30 (10.00%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    7
    0
    0
    0
    2
    8
    0
    17
    17
    15
    7
    0
    25
    0
    NEUTROPENIA
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    3 / 33 (9.09%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    2
    0
    0
    0
    0
    0
    0
    12
    4
    0
    1
    0
    4
    0
    THROMBOCYTOPENIA
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    3
    1
    0
    14
    4
    1
    1
    0
    2
    0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    10 / 47 (21.28%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    12
    2
    1
    1
    0
    1
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    5 / 26 (19.23%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    2
    0
    0
    0
    1
    0
    0
    2
    1
    1
    0
    0
    1
    0
    CONSTIPATION
         subjects affected / exposed
    2 / 26 (7.69%)
    3 / 32 (9.38%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    6 / 33 (18.18%)
    5 / 23 (21.74%)
    4 / 30 (13.33%)
    2 / 2 (100.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    3
    0
    1
    0
    2
    0
    0
    9
    7
    6
    5
    2
    0
    0
    DIARRHOEA
         subjects affected / exposed
    9 / 26 (34.62%)
    9 / 32 (28.13%)
    2 / 3 (66.67%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    17 / 47 (36.17%)
    7 / 33 (21.21%)
    3 / 23 (13.04%)
    5 / 30 (16.67%)
    1 / 2 (50.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    17
    10
    2
    0
    0
    4
    2
    0
    29
    7
    3
    6
    2
    4
    0
    DRY MOUTH
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    4
    2
    0
    0
    0
    1
    0
    DYSPEPSIA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    1
    2
    12
    0
    0
    3
    0
    DYSPHAGIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    1
    0
    0
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    NAUSEA
         subjects affected / exposed
    11 / 26 (42.31%)
    10 / 32 (31.25%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    8 / 22 (36.36%)
    2 / 3 (66.67%)
    0 / 2 (0.00%)
    19 / 47 (40.43%)
    13 / 33 (39.39%)
    6 / 23 (26.09%)
    7 / 30 (23.33%)
    0 / 2 (0.00%)
    11 / 25 (44.00%)
    1 / 1 (100.00%)
         occurrences all number
    22
    11
    2
    0
    0
    11
    2
    0
    46
    49
    14
    11
    0
    44
    1
    OESOPHAGEAL PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    STOMATITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    2
    0
    1
    2
    0
    1
    0
    TOOTHACHE
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    VOMITING
         subjects affected / exposed
    10 / 26 (38.46%)
    7 / 32 (21.88%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    11 / 22 (50.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    18 / 47 (38.30%)
    3 / 33 (9.09%)
    5 / 23 (21.74%)
    5 / 30 (16.67%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    1 / 1 (100.00%)
         occurrences all number
    24
    10
    3
    1
    0
    16
    0
    0
    45
    4
    19
    6
    0
    1
    2
    Hepatobiliary disorders
    HEPATOTOXICITY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    0
    0
    0
    0
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    1 / 33 (3.03%)
    2 / 23 (8.70%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    8
    2
    3
    0
    0
    4
    0
    Skin and subcutaneous tissue disorders
    DERMATITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    DRY SKIN
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    1 / 2 (50.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    1
    0
    0
    3
    1
    2
    1
    1
    1
    0
    ERYTHEMA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    1 / 2 (50.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    7
    3
    0
    0
    1
    1
    0
    HYPERHIDROSIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    3
    2
    1
    2
    0
    7
    0
    PRURITUS
         subjects affected / exposed
    6 / 26 (23.08%)
    6 / 32 (18.75%)
    2 / 3 (66.67%)
    2 / 5 (40.00%)
    0 / 2 (0.00%)
    7 / 22 (31.82%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    8 / 47 (17.02%)
    4 / 33 (12.12%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    1 / 2 (50.00%)
    7 / 25 (28.00%)
    0 / 1 (0.00%)
         occurrences all number
    11
    8
    2
    2
    0
    8
    1
    0
    9
    7
    1
    2
    2
    9
    0
    RASH
         subjects affected / exposed
    13 / 26 (50.00%)
    5 / 32 (15.63%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    2 / 3 (66.67%)
    0 / 2 (0.00%)
    9 / 47 (19.15%)
    4 / 33 (12.12%)
    7 / 23 (30.43%)
    1 / 30 (3.33%)
    1 / 2 (50.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    26
    5
    1
    1
    0
    3
    6
    0
    15
    7
    12
    1
    2
    5
    0
    RASH MACULAR
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    1 / 2 (50.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    1
    0
    0
    RASH MACULO-PAPULAR
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    4
    0
    RASH PRURITIC
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    2 / 3 (66.67%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    URTICARIA
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    HAEMATURIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    5
    0
    1
    0
    0
    0
    0
    PROTEINURIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    5
    0
    URINARY TRACT OBSTRUCTION
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Endocrine disorders
    GLUCOCORTICOID DEFICIENCY
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    HYPERTHYROIDISM
         subjects affected / exposed
    4 / 26 (15.38%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    3 / 3 (100.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    3
    0
    4
    1
    1
    0
    0
    1
    0
    HYPOTHYROIDISM
         subjects affected / exposed
    4 / 26 (15.38%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    7 / 33 (21.21%)
    4 / 23 (17.39%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    5 / 25 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    1
    1
    0
    4
    7
    4
    1
    0
    5
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    4 / 26 (15.38%)
    5 / 32 (15.63%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    7 / 47 (14.89%)
    5 / 33 (15.15%)
    1 / 23 (4.35%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    6
    0
    0
    0
    2
    0
    1
    9
    6
    1
    2
    0
    7
    0
    ARTHRITIS
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    BACK PAIN
         subjects affected / exposed
    7 / 26 (26.92%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    9 / 47 (19.15%)
    3 / 33 (9.09%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    8
    4
    0
    0
    0
    0
    0
    0
    10
    3
    0
    0
    0
    0
    1
    BONE PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    1 / 2 (50.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    3
    1
    0
    3
    0
    0
    0
    1
    1
    0
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MYALGIA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    4 / 33 (12.12%)
    4 / 23 (17.39%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    1
    0
    1
    0
    0
    0
    1
    4
    8
    0
    0
    2
    0
    NECK PAIN
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    0
    1
    2
    0
    1
    0
    3
    0
    PAIN IN EXTREMITY
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    7 / 47 (14.89%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    0
    7
    1
    0
    2
    0
    0
    0
    Infections and infestations
    BACTERAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    2 / 23 (8.70%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    BRONCHITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    5
    0
    0
    1
    3
    0
    0
    0
    0
    0
    CELLULITIS
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    1
    0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 32 (3.13%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    0
    1
    1
    1
    0
    0
    0
    0
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    PNEUMONIA
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    3 / 33 (9.09%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    1 / 2 (50.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    1
    0
    1
    3
    0
    1
    1
    2
    0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 32 (9.38%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    2 / 33 (6.06%)
    1 / 23 (4.35%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    1
    0
    0
    0
    3
    1
    1
    0
    0
    0
    RHINITIS
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    0 / 23 (0.00%)
    1 / 30 (3.33%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    2 / 33 (6.06%)
    3 / 23 (13.04%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    1
    0
    2
    0
    0
    0
    0
    1
    2
    3
    0
    0
    4
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    14 / 47 (29.79%)
    4 / 33 (12.12%)
    0 / 23 (0.00%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    19
    5
    0
    2
    0
    2
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    7 / 26 (26.92%)
    12 / 32 (37.50%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    1 / 2 (50.00%)
    6 / 22 (27.27%)
    2 / 3 (66.67%)
    0 / 2 (0.00%)
    12 / 47 (25.53%)
    6 / 33 (18.18%)
    4 / 23 (17.39%)
    11 / 30 (36.67%)
    0 / 2 (0.00%)
    3 / 25 (12.00%)
    0 / 1 (0.00%)
         occurrences all number
    11
    16
    3
    1
    1
    6
    3
    0
    15
    8
    5
    11
    0
    3
    0
    HYPERCALCAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    3 / 33 (9.09%)
    5 / 23 (21.74%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    1
    3
    8
    4
    0
    3
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    1 / 33 (3.03%)
    0 / 23 (0.00%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    HYPERKALAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    3 / 47 (6.38%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    0
    0
    3
    0
    1
    0
    0
    1
    0
    HYPERNATRAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 47 (0.00%)
    0 / 33 (0.00%)
    2 / 23 (8.70%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    HYPERURICAEMIA
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 32 (3.13%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 47 (2.13%)
    1 / 33 (3.03%)
    3 / 23 (13.04%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    1
    1
    4
    0
    0
    0
    0
    HYPOALBUMINAEMIA
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    6 / 47 (12.77%)
    1 / 33 (3.03%)
    5 / 23 (21.74%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    0
    0
    0
    4
    0
    0
    10
    5
    9
    2
    0
    3
    0
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    4 / 47 (8.51%)
    0 / 33 (0.00%)
    1 / 23 (4.35%)
    0 / 30 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    6
    0
    1
    0
    0
    1
    0
    HYPOKALAEMIA
         subjects affected / exposed
    4 / 26 (15.38%)
    0 / 32 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    9 / 47 (19.15%)
    2 / 33 (6.06%)
    2 / 23 (8.70%)
    3 / 30 (10.00%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    0
    0
    0
    0
    3
    0
    0
    11
    2
    2
    5
    0
    2
    0
    HYPOMAGNESAEMIA
         subjects affected / exposed
    3 / 26 (11.54%)
    3 / 32 (9.38%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    2 / 3 (66.67%)
    0 / 2 (0.00%)
    8 / 47 (17.02%)
    2 / 33 (6.06%)
    4 / 23 (17.39%)
    4 / 30 (13.33%)
    0 / 2 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
         occurrences all number
    14
    3
    0
    0
    0
    0
    3
    0
    13
    3
    5
    6
    0
    2
    0
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 32 (6.25%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    2 / 47 (4.26%)
    2 / 33 (6.06%)
    8 / 23 (34.78%)
    2 / 30 (6.67%)
    0 / 2 (0.00%)
    4 / 25 (16.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    1
    0
    4
    4
    13
    2
    0
    7
    0
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    5 / 26 (19.23%)
    4 / 32 (12.50%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    9 / 47 (19.15%)
    4 / 33 (12.12%)
    5 / 23 (21.74%)
    5 / 30 (16.67%)
    0 / 2 (0.00%)
    5 / 25 (20.00%)
    0 / 1 (0.00%)
         occurrences all number
    12
    15
    0
    4
    0
    3
    0
    0
    9
    13
    11
    8
    0
    7
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2018
    1. Part I Cohort D was added to enroll platinum treatment experienced, CPI treatment experienced, docetaxel treatment experienced stage IV NSCLC participants. Cohort D comprised 3 arms. Arm 1 and Arm 2 explored different treatment schedules for RO6874281 in combination with atezolizumab. Participants in Arm 3 received gemcitabine or vinorelbine treatment and served as control. 2. Part II Cohort E was added to enroll treatment naïve stage IV NSCLC participants that express high levels of PD-L1. Cohort E comprises 2 arms. Arm 1 and Arm 2 explored different treatment schedules for RO6874281 in combination with atezolizumab.
    23 Aug 2018
    1. An additional cohort, Cohort F, was added to Part I of this study. Forty response-evaluable participants were planned for this cohort in order to gain a better understanding of the safety and tolerability of the combination of RO6874281 and atezolizumab on an Q3W schedule in a specific NSCLC. 2. An additional part, Part III, was added to the study design. Part III was dedicated to the exploration of RO6874281 in combination with atezolizumab in metastatic or locally advanced solid cancers with squamous histology. Part III comprised Cohorts G, H, I, and J. 3. Implementation of a 10-mg flat dose based upon a simulation using the population pharmacokinetic model that showed overlapping exposures to the dosing regimens of 10 mg followed by 15 mg.
    29 Mar 2019
    1. An additional four cohorts (ie, Cohorts K, L, M, and N) were added to Part III of this study. 2. The sample size of Cohorts D and E were changed due to early termination of these cohorts. 3. Inclusion criteria were updated to align criteria across studies in the clinical development program and to clarify that the biopsy requirements enabling enrollment of participants with head and neck cancer presenting with one lesion does not apply to participants in Cohorts G, H, K, and L. 4. The evaluation of preliminary activity based on immune-modified (im) RECIST was omitted. 5. A general exclusion criterion (ie, exclusion #21) was added to indicate that a 28-day wash-out period from previous cytostatic treatment was required. 6. Safety information pertaining to the risk associated with atezolizumab was updated by adding myositis as a new identified risk. 7. The defined treatment lengths was updated.
    08 Apr 2019
    The additional four cohorts (i.e., Cohorts K, M, and N and Cohort L) were added to the exclusion criteria.
    16 Dec 2019
    Assessment of echocardiography was removed from the 28-day follow-up visit as the period between discontinuation and follow-up was not long enough to expect any clinically relevant changes in the outcome of repeated testing. 2. Benefit risk was updated with new safety information. The enrollment into this study was suspended for participants that were naïve to checkpoint inhibitor treatment (CPI-naïve participants) that otherwise were eligible for CIT/CPI treatment as part of their 1L or 2L standard of care treatment for metastatic disease. 3. Dose for QW/Q2W RO6874281 were added for Part III.
    25 Jun 2020
    The main purpose of this amendment was to lift the temporary recruitment suspension for CPI-naïve participants that otherwise were eligible for CPI treatment as part of their 1L or 2L standard of care treatment and to resume enrollment for all CPI-naïve participants in study BP40234.
    21 Dec 2020
    1. Severe cutaneous adverse reactions was added as a risk associated with atezolizumab. 2. Events suggestive of hemophagocytic lymphohistiocytosis or macrophage activation syndrome was added to the list of non-serious adverse events of special interest. 3. RO6874281 was replaced by simlukafusp alfa, the international nonproprietary name, throughout the protocol. 4. PD Sample (fluorescence-activated cell sorting [FACS]) Basic, PD Sample (Plasma), PD Sample (Serum) at 24, 36, 48, 60, 72, 84, and 96 weeks after Cycle 1 Day 1 and PD Sample (FACS) Advanced at 24, 48, and 96 weeks after Cycle 1 Day 1 were no longer collected in all cohorts irrespective of the treatment regimens, i.e., Q3W and QW/Q2W. 5. During the further conduct of the study, the collection of the on-treatment biopsy scheduled on Cycle 2 Day 8 and Cycle 3 Day 8 for the Q3W and the QW/Q2W schedule, respectively, were regarded as optional for participants enrolled in Part III. 5. A treatment cap of 24 months was added. However, in case the participant had reached the defined duration and continues to derive benefit, a longer treatment duration might be granted by the Sponsor.

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

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