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    Clinical Trial Results:
    A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies.

    Summary
    EudraCT number
    		 2016-004989-25
    Trial protocol
    		 ES   BE  
    Global end of trial date
    09 Nov 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Changes made to align with changes made to ClinicalTrials.gov results summary.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    INCAGN 1876-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff Drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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
    09 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
    Protection of trial subjects
    This study was to be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, Good Clinical Practices as defined in Title 21 of the United States Code of Federal Regulations Parts 50, 54 56, 312, and Part 11 as well as International Council for Harmonisation Good Clinical Practice (ICH GCP) consolidated guidelines (E6) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Belgium: 27
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    United States: 84
    Worldwide total number of subjects
    145
    EEA total number of subjects
    48
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    94
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled at 32 study centers in Australia, Belgium, Spain, and the United States.

    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
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Arm description
    		 Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Arm title
    		 Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Arm description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Arm description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Arm description
    		 Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Arm description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Arm description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Arm description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Arm description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Arm description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Investigational medicinal product name
    ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/mL concentrate for solution for intravenous infusion

    Arm title
    		 Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Arm description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Arm description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Investigational medicinal product name
    ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Arm title
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg
    Arm description
    		 Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Investigational medicinal product name
    ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/mL concentrate for solution for intravenous infusion

    Arm title
    		 Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg
    Arm description
    		 Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg
    Arm description
    		 Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg
    Arm description
    		 Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg
    Arm description
    		 Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Arm title
    		 Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Arm description
    		 Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentrate for solution for intravenous infusion

    Investigational medicinal product name
    INCAGN01876
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg of INCAGN01876 in 5 milliliters (mL) at a concentration of 10 mg/mL

    Number of subjects in period 1
    		Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Started
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    8
    16
    46
    18
    4
    2
    Completed
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    12
    2
    0
    0
    Not completed
    4
    3
    5
    4
    5
    4
    3
    4
    8
    3
    6
    8
    16
    34
    16
    4
    2
         Adverse event, serious fatal
    2
    2
    4
    3
    4
    4
    3
    4
    5
    2
    6
    6
    12
    25
    11
    3
    2
         Consent withdrawn by subject
    1
    -
    -
    1
    1
    -
    -
    -
    2
    1
    -
    1
    3
    3
    2
    1
    -
         Progressive Disease
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Study terminated by the sponsor
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    4
    -
    -
    -
         Safety follow-up no longer necessary
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Survival follow-up no longer necessary
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -
    -
    -
    -
    -
    1
    -
    -
    1
    1
    1
    2
    -
    -
         Started new treatment
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg
    Reporting group description
    		 Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg Total
    Number of subjects
    		 4 4 5 4 5 4 4 4 8 3 6 8 16 46 18 4 2 145
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 4 1 4 3 2 3 2 1 5 1 4 1 10 30 18 3 2 94
        From 65-84 years
    		 0 3 1 1 3 1 2 3 3 2 2 7 6 16 0 1 0 51
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 51.3 ± 7.37 59.8 ± 14.03 48.0 ± 18.23 62.3 ± 7.04 60.8 ± 12.40 62.5 ± 16.36 63.0 ± 9.90 61.5 ± 11.73 61.8 ± 7.70 67.7 ± 4.16 58.5 ± 11.24 69.1 ± 9.46 59.1 ± 10.48 60.5 ± 9.46 48.6 ± 9.43 54.3 ± 9.29 42.0 ± 16.97 -
    Sex: Female, Male
    Units:
        Female
    		 2 2 5 3 3 3 3 3 5 1 2 3 5 8 18 1 1 68
        Male
    		 2 2 0 1 2 1 1 1 3 2 4 5 11 38 0 3 1 77
    Race/Ethnicity, Customized
    Ethnicity
    Units: Subjects
        White/Caucasian
    		 2 3 4 3 2 3 4 3 6 3 6 8 14 45 16 4 2 128
        Black or African American
    		 1 0 1 1 0 1 0 0 0 0 0 0 1 1 1 0 0 7
        Asian
    		 0 0 0 0 2 0 0 1 1 0 0 0 0 0 1 0 0 5
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Native Hawaiin or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Other: Captured as "Other"
    		 1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 3
        Other: Zimbabwean
    		 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1
        Other: Mexican
    		 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 1 1 0 1 0 0 0 1 0 0 0 1 1 1 0 0 8
        Not Hispanic or Latino
    		 3 3 4 4 4 4 4 4 7 3 6 8 14 43 17 4 2 134
        Unknown or Not Reported
    		 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0 0 0 3

    End points

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    End points reporting groups
    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg
    Reporting group description
    		 Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Primary: Phase 1: Number of participants with any treatment-emergent adverse event (TEAE)

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    End point title
    		 Phase 1: Number of participants with any treatment-emergent adverse event (TEAE) [1] [2]
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
    End point type
    Primary
    End point timeframe
    up to approximately 27.4 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: Statistical analysis was not conducted.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: participants
    4
    4
    5
    4
    5
    4
    4
    4
    7
    3
    6
    No statistical analyses for this end point

    Primary: Phase 2: Objective response rate (ORR) per RECIST v1.1

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    End point title
    		 Phase 2: Objective response rate (ORR) per RECIST v1.1 [3] [4]
    End point description
    ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
    End point type
    Primary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    23.9
    16.7
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Phase 1: ORR per RECIST v1.1

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    End point title
    		 Phase 1: ORR per RECIST v1.1 [5]
    End point description
    ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: Percentage of Participants
        number (not applicable)
    25.0
    0.0
    20.0
    0.0
    0.0
    0.0
    25.0
    25.0
    12.5
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Phase 1: ORR per modified RECIST (mRECIST) v1.1

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    End point title
    		 Phase 1: ORR per modified RECIST (mRECIST) v1.1 [6]
    End point description
    ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: Percentage of Participants
        number (not applicable)
    25.0
    0.0
    20.0
    0.0
    0.0
    0.0
    25.0
    25.0
    12.5
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Phase 2: ORR per mRECIST v1.1

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    End point title
    		 Phase 2: ORR per mRECIST v1.1 [7]
    End point description
    ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    26.1
    16.7
    0.0
    0.0
    No statistical analyses for this end point

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

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    End point title
    		 Phase 1: Duration of response (DOR) per RECIST v1.1 [8]
    End point description
    DOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant’s death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. -9999/9999 = not estimable; too few participants had disease progression or died. Only those participants with a response of CR or PR were analyzed.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    1
    0 [9]
    1
    0 [10]
    0 [11]
    0 [12]
    1
    1
    1
    0 [13]
    0 [14]
    Units: Days
        median (confidence interval 95%)
    9999 (-9999 to 9999)
    ( to )
    573.0 (-9999 to 9999)
    ( to )
    ( to )
    ( to )
    876.0 (-9999 to 9999)
    9999 (-9999 to 9999)
    281.0 (-9999 to 9999)
    ( to )
    ( to )
    Notes
    [9] - Only those participants with a response of CR or PR were analyzed.
    [10] - Only those participants with a response of CR or PR were analyzed.
    [11] - Only those participants with a response of CR or PR were analyzed.
    [12] - Only those participants with a response of CR or PR were analyzed.
    [13] - Only those participants with a response of CR or PR were analyzed.
    [14] - Only those participants with a response of CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Phase 2: DOR per RECIST v1.1

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    End point title
    		 Phase 2: DOR per RECIST v1.1 [15]
    End point description
    DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant’s death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. -9999/9999 = not estimable; too few participants had disease progression or died. Only those participants with a response of CR or PR were analyzed.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    0 [16]
    0 [17]
    11
    3
    0 [18]
    0 [19]
    Units: Days
        median (confidence interval 95%)
    ( to )
    ( to )
    9999 (118.0 to 9999)
    120.0 (113.0 to 9999)
    ( to )
    ( to )
    Notes
    [16] - Only those participants with a response of CR or PR were analyzed.
    [17] - Only those participants with a response of CR or PR were analyzed.
    [18] - Only those participants with a response of CR or PR were analyzed.
    [19] - Only those participants with a response of CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Phase 1: DOR per mRECIST v1.1

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    End point title
    		 Phase 1: DOR per mRECIST v1.1 [20]
    End point description
    DOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant’s death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. -9999/9999 = not estimable.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    1
    0 [21]
    1
    0 [22]
    0 [23]
    0 [24]
    1
    1
    1
    0 [25]
    0 [26]
    Units: Days
        median (confidence interval 95%)
    9999 (-9999 to 9999)
    ( to )
    9999 (-9999 to 9999)
    ( to )
    ( to )
    ( to )
    876.0 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    ( to )
    ( to )
    Notes
    [21] - Only those participants with a response of CR or PR were analyzed
    [22] - Only those participants with a response of CR or PR were analyzed
    [23] - Only those participants with a response of CR or PR were analyzed
    [24] - Only those participants with a response of CR or PR were analyzed
    [25] - Only those participants with a response of CR or PR were analyzed
    [26] - Only those participants with a response of CR or PR were analyzed
    No statistical analyses for this end point

    Secondary: Phase 2: DOR per mRECIST v1.1

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    End point title
    		 Phase 2: DOR per mRECIST v1.1 [27]
    End point description
    DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant’s death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. -9999/9999 = not estimable; too few participants had disease progression or died. Only those participants with a response of CR or PR were analyzed.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    0 [28]
    0 [29]
    12
    3
    0 [30]
    0 [31]
    Units: Days
        median (confidence interval 95%)
    ( to )
    ( to )
    9999 (-9999 to 9999)
    9999 (113.0 to 9999)
    ( to )
    ( to )
    Notes
    [28] - Only those participants with a response of CR or PR were analyzed.
    [29] - Only those participants with a response of CR or PR were analyzed.
    [30] - Only those participants with a response of CR or PR were analyzed.
    [31] - Only those participants with a response of CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Phase 1: Disease control rate (DCR) per RECIST v1.1

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    End point title
    		 Phase 1: Disease control rate (DCR) per RECIST v1.1 [32]
    End point description
    DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: Percentage of Participants
        number (not applicable)
    25.0
    50.0
    20.0
    50.0
    0.0
    25.0
    50.0
    25.0
    50.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Phase 2: DCR per RECIST v1.1

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    End point title
    		 Phase 2: DCR per RECIST v1.1 [33]
    End point description
    DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Percentage of Participants
        number (not applicable)
    37.5
    56.3
    54.3
    55.6
    50.0
    50.0
    No statistical analyses for this end point

    Secondary: Phase 1: DCR per mRECIST v1.1

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    End point title
    		 Phase 1: DCR per mRECIST v1.1 [34]
    End point description
    DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: Percentage of Participants
        number (not applicable)
    25.0
    50.0
    20.0
    50.0
    0.0
    25.0
    50.0
    25.0
    50.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Phase 2: DCR per mRECIST v1.1

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    End point title
    		 Phase 2: DCR per mRECIST v1.1 [35]
    End point description
    DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Percentage of Participants
        number (not applicable)
    37.5
    56.3
    56.5
    55.6
    50.0
    50.0
    No statistical analyses for this end point

    Secondary: Phase 1: Duration of disease control per RECIST v1.1

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    End point title
    		 Phase 1: Duration of disease control per RECIST v1.1 [36]
    End point description
    Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. -9999/9999 = not estimable; too few participants had disease progression or died. Only those participants with a response of SD, CR, or PR were analyzed.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    1
    2
    1
    2
    0 [37]
    1
    2
    1
    4
    0 [38]
    0 [39]
    Units: Days
        arithmetic mean (confidence interval 95%)
    9999 (-9999 to 9999)
    9999 (89.0 to 9999)
    624.0 (-9999 to 9999)
    76.0 (-9999 to 9999)
    ( to )
    167.0 (-9999 to 9999)
    668.5 (125.0 to 9999)
    9999 (-9999 to 9999)
    250.5 (110.0 to 9999)
    ( to )
    ( to )
    Notes
    [37] - Only those participants with a response of SD, CR, or PR were analyzed.
    [38] - Only those participants with a response of SD, CR, or PR were analyzed.
    [39] - Only those participants with a response of SD, CR, or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Phase 2: Duration of disease control per RECIST v1.1

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    End point title
    		 Phase 2: Duration of disease control per RECIST v1.1 [40]
    End point description
    Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. -9999/9999 = not estimable; too few participants had disease progression or died. Only those participants with a response of SD, CR, or PR were analyzed.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    3
    9
    25
    10
    2
    1
    Units: Days
        median (confidence interval 95%)
    218.0 (106.0 to 9999)
    109.0 (63.0 to 9999)
    253.0 (156.0 to 9999)
    168.0 (71.0 to 9999)
    206.5 (118.0 to 9999)
    109.0 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 1: Duration of disease control per mRECIST v1.1

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    End point title
    		 Phase 1: Duration of disease control per mRECIST v1.1 [41]
    End point description
    Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. -9999/9999 = not estimable.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    1
    2
    1
    2
    0 [42]
    1
    2
    1
    4
    0 [43]
    0 [44]
    Units: Days
        arithmetic mean (confidence interval 95%)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    76.0 (-9999 to 9999)
    ( to )
    9999 (-9999 to 9999)
    668.5 (125.0 to 9999)
    9999 (-9999 to 9999)
    9999 (134.0 to 9999)
    ( to )
    ( to )
    Notes
    [42] - Only those participants with a response of SD, CR, or PR were analyzed.
    [43] - Only those participants with a response of SD, CR, or PR were analyzed.
    [44] - Only those participants with a response of SD, CR, or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Phase 2: Duration of disease control per mRECIST v1.1

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    End point title
    		 Phase 2: Duration of disease control per mRECIST v1.1 [45]
    End point description
    Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. -9999/9999 = not estimable.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    3
    9
    26
    10
    2
    1
    Units: Days
        median (confidence interval 95%)
    218.0 (133.0 to 9999)
    168.0 (63.0 to 9999)
    9999 (202.0 to 9999)
    9999 (137.0 to 9999)
    9999 (118.0 to 9999)
    9999 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 1: Progression-free survival (PFS) per RECIST v1.1

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    End point title
    		 Phase 1: Progression-free survival (PFS) per RECIST v1.1 [46]
    End point description
    According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. -9999/9999 = not estimable; too few participants had disease progression or died.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: Days
        median (confidence interval 95%)
    52.5 (48.0 to 9999)
    72.0 (53.0 to 9999)
    53.0 (9.0 to 9999)
    64.0 (48.0 to 9999)
    47.5 (29.0 to 9999)
    60.0 (50.0 to 9999)
    88.5 (44.0 to 9999)
    41.0 (15.0 to 9999)
    110.0 (53.0 to 276.0)
    56.0 (53.0 to 9999)
    54.5 (21.0 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 2: PFS per RECIST v1.1

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    End point title
    		 Phase 2: PFS per RECIST v1.1 [47]
    End point description
    According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. -9999/9999 = not estimable; too few participants had disease progression or died.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Days
        median (confidence interval 95%)
    57.0 (20.0 to 218.0)
    75.0 (45.0 to 120.0)
    115.0 (59.0 to 174.0)
    102.0 (51.0 to 225.0)
    87.0 (52.0 to 9999)
    64.5 (20.0 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 1: PFS per mRECIST v1.1

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    End point title
    		 Phase 1: PFS per mRECIST v1.1 [48]
    End point description
    According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant’s death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). -9999/9999 = not estimable; too few participants had disease progression or died.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: Days
        median (confidence interval 95%)
    66.0 (48.0 to 9999)
    9999 (55.0 to 9999)
    116.0 (64.0 to 9999)
    88.0 (76.0 to 9999)
    57.0 (29.0 to 9999)
    9999 (100.0 to 9999)
    98.0 (52.0 to 9999)
    9999 (97.0 to 9999)
    134.0 (53.0 to 9999)
    128.0 (56.0 to 9999)
    9999 (46.0 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 2: PFS per mRECIST v1.1

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    End point title
    		 Phase 2: PFS per mRECIST v1.1 [49]
    End point description
    According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant’s death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). -9999/9999 = not estimable; too few participants had disease progression or died.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Days
        median (confidence interval 95%)
    85.0 (20.0 to 218.0)
    105.0 (63.0 to 9999)
    235.0 (129.0 to 9999)
    168.0 (51.0 to 9999)
    118.0 (52.0 to 9999)
    9999 (20.0 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 1: Overall survival

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    End point title
    		 Phase 1: Overall survival [50]
    End point description
    Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause. -9999/9999 = not estimable; too few participants had disease progression or died.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Number of subjects analysed
    4
    4
    5
    4
    5
    4
    4
    4
    8
    3
    6
    Units: Days
        median (confidence interval 95%)
    9999 (76.0 to 9999)
    9999 (55.0 to 9999)
    253.0 (77.0 to 9999)
    100.0 (76.0 to 9999)
    289.5 (170.0 to 9999)
    266.5 (100.0 to 9999)
    588.0 (424.0 to 9999)
    200.0 (97.0 to 9999)
    425.0 (110.0 to 9999)
    627.0 (128.0 to 9999)
    229.5 (46.0 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 2: Overall survival

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    End point title
    		 Phase 2: Overall survival [51]
    End point description
    Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause. -9999/9999 = not estimable; too few participants had disease progression or died.
    End point type
    Secondary
    End point timeframe
    up to approximately 44.7 months
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Days
        median (confidence interval 95%)
    290.5 (20.0 to 9999)
    179.0 (75.0 to 404.0)
    491.0 (344.0 to 9999)
    492.0 (92.0 to 733.0)
    485.0 (52.0 to 9999)
    264.0 (20.0 to 9999)
    No statistical analyses for this end point

    Secondary: Phase 2: Number of Participants with any TEAE

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    End point title
    		 Phase 2: Number of Participants with any TEAE [52]
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
    End point type
    Secondary
    End point timeframe
    up to approximately 27.4 months
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not conducted.
    End point values
    		 Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Number of subjects analysed
    8
    16
    46
    18
    4
    2
    Units: Participants
    8
    16
    45
    18
    4
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to approximately 27.4 months
    Adverse event reporting additional description
    TEAEs (AEs reported for the first time or the worsening of pre-existing events after the first dose of study medication) were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

    Reporting group title
    Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W
    Reporting group description
    		 Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 1: INCAGN01876 + Nivolumab + Ipilimumab
    Reporting group description
    		 Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg
    Reporting group description
    		 Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

    Reporting group title
    Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
    Reporting group description
    		 Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    3 / 5 (60.00%)
    2 / 4 (50.00%)
    2 / 5 (40.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    3 / 8 (37.50%)
    1 / 3 (33.33%)
    2 / 6 (33.33%)
    3 / 8 (37.50%)
    11 / 16 (68.75%)
    19 / 46 (41.30%)
    10 / 18 (55.56%)
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    68 / 145 (46.90%)
         number of deaths (all causes)
    2
    2
    4
    3
    4
    4
    4
    3
    5
    2
    6
    6
    12
    25
    11
    3
    2
    98
         number of deaths resulting from adverse events
    2
    0
    0
    1
    0
    1
    1
    0
    0
    0
    1
    1
    3
    7
    1
    0
    0
    18
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer metastatic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cancer pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         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
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Tumour haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Tumour pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Facial pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         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 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Peripheral swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Bronchial obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Haemoptysis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         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 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumothorax
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary artery aneurysm
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    3 / 16 (18.75%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         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 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         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
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebral artery embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cerebral ischaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         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 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         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
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Intestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         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 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cholecystitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         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
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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 / 1
    0 / 0
    0 / 0
    0 / 1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    3 / 46 (6.52%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    8 / 145 (5.52%)
         occurrences causally related to treatment / all
    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 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         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
    2 / 2
    0 / 1
    0 / 0
    0 / 0
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Phase 1: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W Phase 1: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W Phase 1: INCAGN01876 + Nivolumab + Ipilimumab Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + ipilimumab 1 mg/kg Phase 2 GC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 SCCHN: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 CC: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 PD-1/PD-L1 RM: INCAGN01876 300 mg + nivolumab 240 mg Phase 2 Biopsy: INCAGN01876 300 mg + nivolumab 240 mg Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    5 / 5 (100.00%)
    3 / 4 (75.00%)
    5 / 5 (100.00%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    7 / 8 (87.50%)
    3 / 3 (100.00%)
    6 / 6 (100.00%)
    8 / 8 (100.00%)
    15 / 16 (93.75%)
    43 / 46 (93.48%)
    18 / 18 (100.00%)
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    139 / 145 (95.86%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Tumour pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Flushing
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    Hot flush
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    4 / 46 (8.70%)
    3 / 18 (16.67%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    8 / 145 (5.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    5
    3
    0
    0
    9
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    3 / 46 (6.52%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    6 / 145 (4.14%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    3
    1
    0
    0
    6
    Orthostatic hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Peripheral coldness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    7 / 46 (15.22%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    13 / 145 (8.97%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    2
    10
    2
    0
    0
    17
    Catheter site pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    3
    Chest discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    2
    Chills
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    6 / 8 (75.00%)
    5 / 16 (31.25%)
    15 / 46 (32.61%)
    5 / 18 (27.78%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    40 / 145 (27.59%)
         occurrences all number
    0
    1
    2
    0
    0
    2
    0
    1
    0
    1
    1
    6
    6
    22
    5
    1
    0
    48
    Inadequate analgesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Medical device site pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    2
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    1
    0
    4
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    3 / 16 (18.75%)
    3 / 46 (6.52%)
    2 / 18 (11.11%)
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    17 / 145 (11.72%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    1
    2
    3
    3
    2
    2
    1
    17
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    6 / 145 (4.14%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    3
    0
    0
    0
    0
    4
    0
    0
    0
    8
    Peripheral swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    3 / 16 (18.75%)
    7 / 46 (15.22%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    15 / 145 (10.34%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    1
    1
    3
    8
    0
    0
    0
    17
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Reproductive system and breast disorders
    Breast hyperplasia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Breast pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Menopausal symptoms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pelvic discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Pelvic pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    3
    Penile pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Pruritus genital
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Cough
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    3 / 8 (37.50%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    3 / 8 (37.50%)
    2 / 16 (12.50%)
    12 / 46 (26.09%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    27 / 145 (18.62%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    2
    3
    0
    1
    3
    2
    14
    3
    0
    0
    31
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    5 / 16 (31.25%)
    5 / 46 (10.87%)
    1 / 18 (5.56%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    23 / 145 (15.86%)
         occurrences all number
    0
    1
    1
    1
    1
    1
    0
    0
    2
    1
    1
    1
    5
    5
    1
    2
    0
    23
    Dysphonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    3
    Haemoptysis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    3
    Hypoxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Nasal congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    4
    Oropharyngeal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    8 / 145 (5.52%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    3
    0
    0
    1
    8
    Pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    2
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    2
    Productive cough
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    6 / 46 (13.04%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    8 / 145 (5.52%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    6
    0
    0
    0
    8
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Respiratory disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    2
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    3 / 16 (18.75%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    6 / 145 (4.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    3
    1
    0
    1
    0
    6
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    3
    Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    1
    0
    4
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    2 / 16 (12.50%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    7 / 145 (4.83%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    2
    0
    1
    0
    7
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    6
    Amylase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    0
    0
    0
    8
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    7 / 145 (4.83%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    0
    1
    0
    8
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    Blood bilirubin increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    Blood cholesterol increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    2 / 46 (4.35%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    7 / 145 (4.83%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    1
    5
    1
    0
    0
    10
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Clostridium test positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Heart rate increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11
    0
    0
    0
    11
    Lipase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    3
    Neutrophil count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Protein total decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Troponin I increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    3 / 16 (18.75%)
    4 / 46 (8.70%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    11 / 145 (7.59%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    5
    2
    0
    0
    12
    Injury, poisoning and procedural complications
    Corneal abrasion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    3
    Infusion related reaction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    1
    0
    4
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    2
    Seroma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    3
    Synovial rupture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    3
    Pericardial effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    5 / 145 (3.45%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    1
    5
    Nervous system disorders
    Allodynia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Balance disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    3 / 46 (6.52%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    13 / 145 (8.97%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    2
    0
    0
    0
    2
    0
    2
    3
    1
    0
    1
    14
    Dizziness postural
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    3
    Encephalopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    4 / 46 (8.70%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    13 / 145 (8.97%)
         occurrences all number
    0
    2
    1
    0
    0
    1
    0
    1
    1
    0
    0
    0
    4
    5
    1
    0
    0
    16
    Lethargy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    4
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Somnolence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    2
    Tension headache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Tremor
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    3 / 6 (50.00%)
    0 / 8 (0.00%)
    3 / 16 (18.75%)
    7 / 46 (15.22%)
    5 / 18 (27.78%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    25 / 145 (17.24%)
         occurrences all number
    1
    2
    1
    0
    1
    0
    1
    0
    1
    1
    3
    0
    3
    12
    6
    0
    0
    32
    Increased tendency to bruise
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Lymph node pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    2
    Tinnitus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Iridocyclitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Retinal tear
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    3
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    3 / 16 (18.75%)
    1 / 46 (2.17%)
    6 / 18 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    13 / 145 (8.97%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    3
    1
    6
    0
    0
    13
    Abdominal distension
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    5
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Ascites
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    4 / 16 (25.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    9 / 145 (6.21%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    6
    0
    1
    0
    0
    11
    Constipation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    3 / 16 (18.75%)
    8 / 46 (17.39%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    21 / 145 (14.48%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    2
    1
    2
    1
    0
    1
    3
    8
    2
    0
    0
    22
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    6 / 16 (37.50%)
    8 / 46 (17.39%)
    8 / 18 (44.44%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    27 / 145 (18.62%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    1
    1
    7
    11
    8
    0
    0
    31
    Dry mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    1 / 16 (6.25%)
    2 / 46 (4.35%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    7 / 145 (4.83%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    1
    3
    1
    0
    0
    8
    Duodenal ulcer
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dyschezia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    5
    Dysphagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    4 / 46 (8.70%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    11 / 145 (7.59%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    1
    1
    1
    0
    2
    4
    0
    0
    0
    11
    Eructation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    6
    Gastritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    2
    0
    0
    5
    Haemorrhoids
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    3
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    4 / 8 (50.00%)
    2 / 3 (66.67%)
    0 / 6 (0.00%)
    3 / 8 (37.50%)
    6 / 16 (37.50%)
    7 / 46 (15.22%)
    5 / 18 (27.78%)
    1 / 4 (25.00%)
    2 / 2 (100.00%)
    35 / 145 (24.14%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    2
    0
    6
    3
    0
    3
    7
    8
    5
    1
    2
    40
    Oesophageal stenosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    2
    0
    1
    0
    0
    0
    5
    Proctalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Varices oesophageal
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    4 / 8 (50.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    4 / 16 (25.00%)
    5 / 46 (10.87%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    21 / 145 (14.48%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    2
    0
    5
    0
    0
    0
    4
    8
    3
    0
    1
    26
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    3
    Hyperhidrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    3 / 5 (60.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    3 / 8 (37.50%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    3 / 8 (37.50%)
    3 / 16 (18.75%)
    9 / 46 (19.57%)
    7 / 18 (38.89%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    36 / 145 (24.83%)
         occurrences all number
    2
    0
    2
    0
    3
    0
    1
    0
    3
    1
    1
    4
    5
    9
    7
    3
    0
    41
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    3 / 5 (60.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    3 / 16 (18.75%)
    6 / 46 (13.04%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    22 / 145 (15.17%)
         occurrences all number
    0
    0
    1
    0
    3
    1
    1
    2
    2
    0
    1
    3
    3
    8
    1
    0
    0
    26
    Rash erythematous
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    2
    Rash maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    6 / 145 (4.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    2
    0
    2
    0
    7
    Rash pruritic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    3
    Bladder irritation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Chromaturia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Chronic kidney disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    3
    Incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Nephrolithiasis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    3
    Proteinuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Renal impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Ureteric obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Urinary tract obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    Hypothyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    7 / 46 (15.22%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    11 / 145 (7.59%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    9
    1
    0
    0
    13
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    3 / 4 (75.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    3 / 16 (18.75%)
    7 / 46 (15.22%)
    1 / 18 (5.56%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    21 / 145 (14.48%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    3
    1
    0
    2
    0
    3
    7
    1
    2
    0
    22
    Back pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    4 / 16 (25.00%)
    2 / 46 (4.35%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    16 / 145 (11.03%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    2
    2
    0
    1
    1
    4
    2
    1
    0
    0
    16
    Flank pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Muscle disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    2
    Muscular weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    4
    Myalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    8 / 145 (5.52%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    3
    0
    1
    1
    8
    Neck pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    0
    4
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    8 / 145 (5.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    1
    0
    1
    1
    1
    1
    0
    8
    Tendon pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Cestode infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Diverticulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    3
    Fungal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Folliculitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    4
    Fungal skin infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    3
    Helminthic infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Hordeolum
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    Infected cyst
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Mucosal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    7 / 145 (4.83%)
         occurrences all number
    3
    0
    0
    0
    0
    1
    2
    0
    2
    0
    0
    2
    0
    1
    0
    0
    0
    11
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Omphalitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    1
    0
    0
    5
    Penile infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    3
    Pyelonephritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pyelonephritis acute
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Scrotal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Skin infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    4
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    6 / 46 (13.04%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    13 / 145 (8.97%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    2
    1
    0
    2
    0
    8
    2
    0
    0
    17
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    4 / 18 (22.22%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    9 / 145 (6.21%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    5
    7
    0
    0
    0
    0
    0
    6
    0
    0
    19
    Urosepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    3 / 6 (50.00%)
    1 / 8 (12.50%)
    7 / 16 (43.75%)
    3 / 46 (6.52%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    22 / 145 (15.17%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    1
    0
    2
    1
    3
    1
    7
    3
    1
    0
    1
    22
    Dehydration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    1
    0
    0
    2
    0
    0
    0
    6
    Folate deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    3 / 46 (6.52%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    6 / 145 (4.14%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    2
    0
    0
    7
    Hyperglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    4
    Hypernatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    4 / 145 (2.76%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    4
    Hypoglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    2 / 16 (12.50%)
    0 / 46 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    3
    Hypokalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 145 (3.45%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    5
    Hypomagnesaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    2 / 46 (4.35%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    3
    Hyponatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    1 / 16 (6.25%)
    3 / 46 (6.52%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    7 / 145 (4.83%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    3
    0
    0
    0
    7
    Iron deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Malnutrition
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    Polydipsia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 16 (0.00%)
    0 / 46 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 145 (0.69%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 16 (0.00%)
    1 / 46 (2.17%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2017
    The primary purpose of this amendment was to update the sponsor name and address to Incyte Biosciences International Sàrl.
    22 Aug 2017
    The primary purpose of this amendment was to address clinical trial application review comments from the Belgian and Spanish regulatory agencies.
    24 Oct 2018
    The primary purpose of this amendment was (1) to introduce mandatory pretreatment biopsy sample collection for all participants to be enrolled in the Phase 2 portion of the study, and (2) to explore the combination therapy of INCAGN01876 with nivolumab in participants with programmed cell death protein (PD-1) refractory squamous cell carcinoma of head and neck (SCCHN).
    22 Jan 2021
    The primary purpose of this amendment was to provide guidance for the management of ongoing participants, as enrollment was complete and sufficient data had been collected for primary and secondary endpoint analysis.

    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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