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    Clinical Trial Results:
    Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts

    Summary
    EudraCT number
    		 2019-002752-16
    Trial protocol
    		 DK   ES   NL   FR   BE  
    Global end of trial date
    28 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2024
    First version publication date
    02 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GCT3009-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04358458
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Genmab A/S
    Sponsor organisation address
    Carl Jacobsens Vej 30, Valby, Denmark, 2500
    Public contact
    Medical Lead, Genmab, +45 7020 2728, regulatory@genmab.com
    Scientific contact
    Medical Lead, Genmab, +45 7020 2728, regulatory@genmab.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
    28 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to determine the anti-tumor efficacy in subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.
    Protection of trial subjects
    All the participants will sign the informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Mar 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    46
    EEA total number of subjects
    25
    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)
    16
    From 65 to 84 years
    29
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at investigative sites in Belgium, Denmark, Netherlands, Spain and the United States from 13 March 2020 to 28 July 2023.

    Pre-assignment
    Screening details
    		 This study was to be conducted in 2 parts; Part 1 was the dose-escalation phase and Part 2 was the expansion phase. However, due to early termination of the study, the sponsor decided not to conduct the expansion phase (Part 2).

    Period 1
    Period 1 title
    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
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1)
    Arm description
    		 Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: GEN3009 Dose Level B in S1
    Arm description
    		 Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: GEN3009 Dose Level C in S1
    Arm description
    		 Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: GEN3009 Dose Level D in S1
    Arm description
    		 Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at Cycle 1 Day 1 (C1D1) and the remaining amount at Day 2 (C1D2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: GEN3009 Dose Level D in Schedule 2 (S2)
    Arm description
    		 Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: GEN3009 Dose Level E in S1
    Arm description
    		 Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: GEN3009 Dose Level F in S1
    Arm description
    		 Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Arm title
    		 Part 1: GEN3009 Dose Level G in S1
    Arm description
    		 Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEN3009
    Investigational medicinal product code
    Other name
    DuoHexaBody®-CD37
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as specified in the treatment arm.

    Number of subjects in period 1
    		Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Started
    3
    4
    7
    10
    3
    10
    3
    6
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    3
    4
    7
    10
    3
    10
    3
    6
         Consent withdrawn by subject
    -
    -
    1
    1
    -
    1
    -
    1
         Death
    1
    1
    3
    8
    1
    6
    2
    3
         Sponsor request
    2
    3
    3
    -
    2
    3
    1
    1
         Site is closing study participation
    -
    -
    -
    1
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: GEN3009 Dose Level A in Schedule 1 (S1)
    Reporting group description
    		 Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level B in S1
    Reporting group description
    		 Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level C in S1
    Reporting group description
    		 Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level D in S1
    Reporting group description
    		 Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at Cycle 1 Day 1 (C1D1) and the remaining amount at Day 2 (C1D2).

    Reporting group title
    Part 1: GEN3009 Dose Level D in Schedule 2 (S2)
    Reporting group description
    		 Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.

    Reporting group title
    Part 1: GEN3009 Dose Level E in S1
    Reporting group description
    		 Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group title
    Part 1: GEN3009 Dose Level F in S1
    Reporting group description
    		 Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group title
    Part 1: GEN3009 Dose Level G in S1
    Reporting group description
    		 Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1 Total
    Number of subjects
    		 3 4 7 10 3 10 3 6 46
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65 ( 3.46 ) 54.5 ( 8.81 ) 74.6 ( 8.68 ) 67.1 ( 9.89 ) 63.3 ( 16.86 ) 69.4 ( 10.23 ) 70.3 ( 9.87 ) 60.8 ( 17.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 2 2 0 2 1 1 11
        Male
    		 1 3 5 8 3 8 2 5 35
    Ethnicity
    Units: Subjects
        Missing
    		 0 2 5 4 0 8 3 3 25
        Not Hispanic or Latino
    		 2 2 2 6 3 0 0 3 18
        Not Reported
    		 1 0 0 0 0 2 0 0 3
    Race
    Units: Subjects
        Black or African American
    		 1 1 0 2 0 0 0 1 5
        Missing
    		 0 0 0 0 0 1 0 0 1
        Not Reported
    		 0 0 0 1 0 0 0 0 1
        Other
    		 0 0 0 0 0 1 0 0 1
        White
    		 2 3 7 7 3 8 3 5 38

    End points

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    End points reporting groups
    Reporting group title
    Part 1: GEN3009 Dose Level A in Schedule 1 (S1)
    Reporting group description
    		 Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level B in S1
    Reporting group description
    		 Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level C in S1
    Reporting group description
    		 Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level D in S1
    Reporting group description
    		 Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at Cycle 1 Day 1 (C1D1) and the remaining amount at Day 2 (C1D2).

    Reporting group title
    Part 1: GEN3009 Dose Level D in Schedule 2 (S2)
    Reporting group description
    		 Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.

    Reporting group title
    Part 1: GEN3009 Dose Level E in S1
    Reporting group description
    		 Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group title
    Part 1: GEN3009 Dose Level F in S1
    Reporting group description
    		 Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group title
    Part 1: GEN3009 Dose Level G in S1
    Reporting group description
    		 Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

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

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    End point title
    		 Number of Participants With Dose Limiting Toxicities (DLTs) [1]
    End point description
    DLTs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, except for TLS (Cairo-Bishop grading) and CRS/ICANS (Lee et al., 2019). These criteria include: all Grade 5 toxicities; hematologic events including thrombocytopenia Grade 4, neutropenia Grade 4, Febrile neutropenia Grade 3 or 4, Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3, anemia of Grade 4 and tumor lysis syndrome (TLS) Grade 4; and non-hematologic AEs of Grade 3 or higher excluding certain fevers, hypotension, laboratory values, Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), nausea, vomiting, diarrhea, fatigue/asthenia, or alopecia (no grading), which meet certain additional criteria. The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
    End point type
    Primary
    End point timeframe
    During the first treatment cycle (Cycle length=28 days)
    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: Only descriptive analysis was planned to be analysed.
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: participants
    0
    0
    0
    0
    0
    0
    0
    3
    No statistical analyses for this end point

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

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs [2]
    End point description
    An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as an AE that meets one of the following criteria: is fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is “medically significant”]); required inpatient hospitalization or prolongation of existing hospitalization. TEAEs are defined as AEs which begin, or worsen, during the on-treatment period ending 4 weeks after the last dose of study medication. The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
    End point type
    Primary
    End point timeframe
    From first dose until 30 days after the last dose (up to 15.5 months)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed.
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: participants
        Participants with TEAEs
    3
    4
    7
    10
    3
    10
    3
    6
        Participants with Serious TEAEs
    0
    0
    4
    7
    2
    4
    2
    4
    No statistical analyses for this end point

    Primary: Number of Participants With AEs of Special Interest (AESI)

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    End point title
    		 Number of Participants With AEs of Special Interest (AESI) [3]
    End point description
    AESIs are defined as events (serious or non-serious) that are of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
    End point type
    Primary
    End point timeframe
    From first dose until 30 days after the last dose (up to 15.5 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: Only descriptive analysis was planned to be analysed.
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: participants
    1
    1
    7
    9
    3
    10
    3
    5
    No statistical analyses for this end point

    Primary: Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs

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    End point title
    		 Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs [4]
    End point description
    Laboratory parameters included hematology, serum chemistries and urinalysis. Clinically significant laboratory abnormalities were based upon the Investigator's discretion. Laboratory parameters captured as AEs are reported in this outcome measure. The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
    End point type
    Primary
    End point timeframe
    From first dose until 30 days after the last dose (up to 15.5 months)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed.
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: participants
        Blood creatinine increased
    0
    0
    2
    1
    0
    0
    0
    1
        Blood alkaline phosphatase increased
    0
    0
    1
    0
    0
    1
    0
    1
        Blood lactate dehydrogenase increased
    0
    0
    1
    0
    0
    1
    0
    0
        Alanine aminotransferase increased
    0
    0
    1
    0
    0
    0
    0
    0
        Aspartate aminotransferase increased
    0
    0
    1
    0
    0
    0
    0
    0
        Blood creatine increased
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Clinically Notable Vital Signs

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    End point title
    		 Number of Participants With Clinically Notable Vital Signs [5]
    End point description
    Criteria for clinically notable (elevated and below normal values respectively) vital signs are as follows: Systolic Blood Pressure (SBP): ≥180 millimeters of mercury (mmHg) and an increase ≥20 mmHg from baseline, ≤90 mmHg and a decrease ≥20 mmHg from baseline; Diastolic Blood Pressure (DBP): ≥105 mmHg and an increase ≥15 mmHg from baseline, ≤50 mmHg and a decrease ≥15 mmHg from baseline; Heart rate: ≥120 beats per minute (bpm) with an increase of ≥15 bpm from baseline, ≤50 bpm and a decrease ≥15 bpm from baseline; Temperature: > 38 degree Celsius (°C), and < 35°C. Number of participants with clinically notable elevated and below normal vital signs values up to end of treatment are reported. The Safety analysis set included all participants who had received at least 1 dose of GEN3009. ‘Number of subjects analysed’ indicates the number of participants with data available for outcome measure analysis.
    End point type
    Primary
    End point timeframe
    From first dose up to end of treatment (up to 14.5 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed.
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    5
    9
    3
    8
    2
    5
    Units: participants
        SBP: Elevated
    0
    0
    0
    0
    0
    0
    0
    0
        SBP: Below Normal
    0
    0
    0
    1
    0
    2
    0
    1
        DBP: Elevated
    0
    0
    0
    0
    0
    0
    0
    0
        DBP: Below Normal
    0
    0
    0
    0
    0
    0
    0
    0
        Heart Rate: Elevated
    0
    0
    0
    0
    0
    0
    0
    0
        Heart Rate: Below Normal
    0
    0
    0
    0
    0
    0
    0
    0
        Temperature: Elevated
    0
    0
    0
    0
    0
    0
    0
    0
        Temperature: Below Normal
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Dose Delays and Dose Interruptions

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    End point title
    		 Number of Participants With Dose Delays and Dose Interruptions [6]
    End point description
    Number of participants with dose delays and dose Interruptions due to AE, Coronavirus disease 2019 (COVID-19), drug administration issues and un-specified reason are reported. The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
    End point type
    Primary
    End point timeframe
    From first dose until 30 days after the last dose (up to 15.5 months)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed.
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: participants
        Dose delay due to AE
    0
    0
    4
    1
    1
    2
    1
    2
        Dose delay due to COVID-19
    0
    0
    0
    0
    0
    0
    0
    0
        Dose delay due to un-specified reason
    0
    0
    1
    1
    0
    1
    1
    0
        Dose interruption due to AE
    0
    1
    7
    9
    3
    10
    3
    5
        Dose interruption due to Drug administration issue
    1
    0
    0
    0
    0
    1
    0
    0
        Dose interruption due to un-specified reason
    0
    0
    1
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Actual Dose Intensity

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    End point title
    		 Actual Dose Intensity [7]
    End point description
    Actual dose intensity (milligrams per cycle [mg/cycle]) is calculated as cumulative dose/number of cycles initiated. The Safety analysis set included all participants who had received at least 1 dose of GEN3009. 999 indicates that data was not evaluable at given time point. 9999 indicates that standard deviation was not estimable as there was only 1 participant. ‘n’ signifies the number of participants analysed at specific timepoint.
    End point type
    Primary
    End point timeframe
    From first dose until 30 days after the last dose (up to 15.5 months)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed.
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: mg/cycle
    arithmetic mean (standard deviation)
        Cycle 1-3
    114.67 ( 112.10 )
    720.00 ( 0.00 )
    1389.46 ( 278.91 )
    2501.53 ( 992.91 )
    2515.85 ( 1053.90 )
    3903.62 ( 1135.72 )
    5957.23 ( 766.90 )
    6973.78 ( 1072.58 )
        Cycle 4-9 (n= 0, 1, 4, 1, 0, 1, 2, 0)
    999 ( 999 )
    363.71 ( 9999 )
    799.71 ( 10.64 )
    1527.27 ( 9999 )
    999 ( 999 )
    2400.00 ( 9999 )
    2953.02 ( 349.28 )
    999 ( 999 )
        Cycle 10-until end of study (n=0,0,1,0,0,0,0,0)
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    318.94 ( 9999 )
    999 ( 999 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Apparent Total Plasma Clearance (CL) of GEN3009

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    End point title
    		 Apparent Total Plasma Clearance (CL) of GEN3009
    End point description
    The pharmacokinetic analysis set (PAS) includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 hours (h) and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    Units: milliliter per day (mL/day)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [8] - Data was not estimable because the values were below the lower limit of quantification (LLOQ).
    [9] - Data was not estimable because the values were below the LLOQ.
    [10] - Data was not estimable because the values were below the LLOQ.
    [11] - Data was not estimable because the values were below the LLOQ.
    [12] - Data was not estimable because the values were below the LLOQ.
    [13] - Data was not estimable because the values were below the LLOQ.
    [14] - Data was not estimable because the values were below the LLOQ.
    [15] - Data was not estimable because the values were below the LLOQ.
    No statistical analyses for this end point

    Secondary: Volume of Distribution of GEN3009

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    End point title
    		 Volume of Distribution of GEN3009
    End point description
    Volume of distribution is measured in milliliters per cubic centimeters (mL/cm^3). The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    Units: mL/cm^3
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [16] - Data was not estimable because the values were below the LLOQ.
    [17] - Data was not estimable because the values were below the LLOQ.
    [18] - Data was not estimable because the values were below the LLOQ.
    [19] - Data was not estimable because the values were below the LLOQ.
    [20] - Data was not estimable because the values were below the LLOQ.
    [21] - Data was not estimable because the values were below the LLOQ.
    [22] - Data was not estimable because the values were below the LLOQ.
    [23] - Data was not estimable because the values were below the LLOQ.
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Day 7 of GEN3009

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    End point title
    		 Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Day 7 of GEN3009
    End point description
    The PAS includes all participants who have been exposed to GEN3009 and had had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 999 indicates that data was not evaluable at given time point. 9999 indicates that standard deviation was not estimable as there was only 1 participant. ‘n’ signifies the number of participants analysed in a specific cycle.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2 and 4 (S2 only); 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    0 [24]
    0 [25]
    7
    10
    3
    10
    3
    6
    Units: microgram*day per milliliter (ug*day/mL)
    arithmetic mean (standard deviation)
        Cycle 1 (n= 0, 0, 2, 1, 1, 2, 3, 3)
    ( )
    ( )
    159.2796 ( 95.7330 )
    181.5966 ( 22.1333 )
    260.8704 ( 9999 )
    219.1863 ( 46.3749 )
    353.5017 ( 177.2169 )
    389.0321 ( 126.8407 )
        Cycle 2 (n= 0, 0, 1, 2, 0, 2, 3, 0)
    ( )
    ( )
    132.6580 ( 9999 )
    159.3302 ( 22.1333 )
    999 ( 999 )
    159.3456 ( 98.0641 )
    363.4413 ( 190.0120 )
    999 ( 999 )
    Notes
    [24] - Data was not estimable because the values were below the LLOQ.
    [25] - Data was not estimable because the values were below the LLOQ.
    No statistical analyses for this end point

    Secondary: AUC From Time 0 to Infinity (AUCinf) of GEN3009

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    End point title
    		 AUC From Time 0 to Infinity (AUCinf) of GEN3009
    End point description
    The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 999 indicates that data was not evaluable at given time point. 9999 indicates that standard deviation was not estimable as there was only 1 participant. ‘n’ signifies the number of participants analysed in a specific cycle.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: ug*day/mL
    arithmetic mean (standard deviation)
        Cycle 1 (n= 2, 4, 6, 7, 2, 7, 3, 5)
    6.0154 ( 3.8503 )
    56.3289 ( 22.4400 )
    136.8615 ( 72.7498 )
    163.9206 ( 52.0135 )
    332.1408 ( 73.1435 )
    192.0412 ( 90.3476 )
    358.0010 ( 183.3857 )
    335.8745 ( 117.1831 )
        Cycle 2 (n= 2, 3, 5, 4, 3, 5, 3, 0)
    5.9939 ( 0.6498 )
    46.4191 ( 9.8966 )
    139.9286 ( 61.7235 )
    127.4566 ( 49.8017 )
    957.4149 ( 1427.7939 )
    159.8668 ( 73.6559 )
    363.7766 ( 190.3613 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: AUC From Time 0 to Time of Last Dose (AUClast) of GEN3009

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    End point title
    		 AUC From Time 0 to Time of Last Dose (AUClast) of GEN3009
    End point description
    The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. ‘n’ signifies the number of participants analysed in a specific cycle. 999 indicates that data was not evaluable at given time point. 9999 indicates that standard deviation was not estimable as there was only 1 participant.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: ug*day/mL
    arithmetic mean (standard deviation)
        Cycle 1 (n= 2, 4, 7, 8, 3, 9, 3, 6)
    4.5524 ( 2.3467 )
    51.0701 ( 17.1901 )
    103.4129 ( 73.3627 )
    148.4079 ( 41.7750 )
    467.9622 ( 283.7778 )
    150.7393 ( 96.0893 )
    353.5017 ( 177.2169 )
    327.1762 ( 109.9472 )
        Cycle 2 (n= 2, 3, 5, 5, 3, 5, 3, 0)
    4.4707 ( 1.3098 )
    45.0924 ( 9.1404 )
    121.5349 ( 53.0658 )
    103.5413 ( 61.7884 )
    441.7798 ( 542.0539 )
    152.4631 ( 74.1040 )
    363.4413 ( 190.0120 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of GEN3009

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of GEN3009
    End point description
    The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 999 indicates that data was not evaluable at given time point. 9999 indicates that standard deviation was not estimable as there was only 1 participant. ‘n’ signifies the number of participants analysed in a specific cycle.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: microgram per milliliter (ug/mL)
    arithmetic mean (standard deviation)
        Cycle 1 (n= 2, 4, 7, 8, 3, 9, 3, 6)
    8.3000 ( 3.5355 )
    43.4000 ( 12.7674 )
    89.8714 ( 39.8257 )
    139.0000 ( 43.8341 )
    363.0667 ( 460.6843 )
    144.4778 ( 79.0905 )
    317.3333 ( 51.4328 )
    352.6667 ( 58.5514 )
        Cycle 2 (n= 2, 3, 5, 5, 3, 5, 3, 0)
    8.1050 ( 3.6699 )
    46.1667 ( 2.7934 )
    118.4800 ( 29.9458 )
    147.4000 ( 52.7286 )
    572.0000 ( 708.4659 )
    237.0000 ( 30.8869 )
    394.6667 ( 109.5871 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Time to Reach Cmax (Tmax) of GEN3009

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    End point title
    		 Time to Reach Cmax (Tmax) of GEN3009
    End point description
    The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 999 indicates that data was not evaluable at given time point. 9999 indicates that standard deviation was not estimable as there was only 1 participant. ‘n’ signifies the number of participants analysed in a specific cycle.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: days
    arithmetic mean (standard deviation)
        Cycle 1 (n= 2, 4, 7, 8, 3, 9, 3, 6)
    0.0765 ( 0.0120 )
    0.1490 ( 0.0957 )
    0.2084 ( 0.0553 )
    0.6039 ( 0.6768 )
    1.2123 ( 1.5987 )
    0.5030 ( 0.2908 )
    1.3817 ( 0.0890 )
    1.2580 ( 0.0771 )
        Cycle 2 (n= 2, 3, 5, 5, 3, 5, 3, 0)
    0.0445 ( 0.0007 )
    0.1650 ( 0.1643 )
    0.1656 ( 0.0820 )
    0.2740 ( 0.3010 )
    0.2030 ( 0.0346 )
    0.1620 ( 0.0595 )
    0.1983 ( 0.0535 )
    999 ( 999 )
    No statistical analyses for this end point

    Secondary: Trough Concentrations (Ctrough) of GEN3009

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    End point title
    		 Trough Concentrations (Ctrough) of GEN3009
    End point description
    The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    Units: μg/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [26] - Data was not estimable because the values were below the LLOQ.
    [27] - Data was not estimable because the values were below the LLOQ.
    [28] - Data was not estimable because the values were below the LLOQ.
    [29] - Data was not estimable because the values were below the LLOQ.
    [30] - Data was not estimable because the values were below the LLOQ.
    [31] - Data was not estimable because the values were below the LLOQ.
    [32] - Data was not estimable because the values were below the LLOQ.
    [33] - Data was not estimable because the values were below the LLOQ.
    No statistical analyses for this end point

    Secondary: Terminal Elimination Half-Life (t 1/2) of GEN3009

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    End point title
    		 Terminal Elimination Half-Life (t 1/2) of GEN3009
    End point description
    The pharmacokinetic analysis set (PAS) includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    0 [34]
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [34] - Data was not estimable because the values were below the LLOQ.
    [35] - Data was not estimable because the values were below the LLOQ.
    [36] - Data was not estimable because the values were below the LLOQ.
    [37] - Data was not estimable because the values were below the LLOQ.
    [38] - Data was not estimable because the values were below the LLOQ.
    [39] - Data was not estimable because the values were below the LLOQ.
    [40] - Data was not estimable because the values were below the LLOQ.
    [41] - Data was not estimable because the values were below the LLOQ.
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive Anti-drug Antibodies (ADAs)

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    End point title
    		 Number of Participants With Positive Anti-drug Antibodies (ADAs)
    End point description
    Venous blood samples will be collected for measurement of serum concentrations of ADAs. Number of participants with positive ADAs are reported in this outcome measure. The detection of ADAs was performed using validated, specific and sensitive Electrochemiluminescence Immunoassay (ECLIA) method. The immunogenicity analysis set included all participants who had received at least 1 dose of study drug and had a baseline and at least 1 evaluable on-treatment ADA sample.
    End point type
    Secondary
    End point timeframe
    From first dose until 30 days after the last dose (up to 15.5 months)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    3
    7
    8
    3
    9
    3
    3
    Units: participants
    1
    0
    2
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    DoR is defined as the time from the first documentation of objective tumor response [Complete response (CR) or Partial response (PR)] to the date of first disease progression (PD) or death as assessed by the investigator based on Lugano criteria for B-cell non-Hodgkin lymphoma (B-cell NHL) and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) for chronic lymphocytic leukemia (CLL). Detailed definition of CR, PR and PD as per Lugano and iwCLL criteria in the protocol appendices. The Full analysis set (FAS) comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009. 'Number of subjects analysed' signified participants who achieved CR or PR. 99999= Median and limits of CI not reached due to less number of participants with events. 0.9999 indicates "NA" which means that lower limit of CI not reached for Part 1: GEN3009 Dose Level G in S1.
    End point type
    Secondary
    End point timeframe
    From date of first documented CR or PR up to disease progression or death (up to approximately 3 years 4 months)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    0 [42]
    0 [43]
    3
    0 [44]
    1
    3
    2
    1
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    15.9 (2.9 to 99999)
    ( to )
    99999 (99999 to 99999)
    1.4 (1.4 to 99999)
    99999 (99999 to 99999)
    4.1 (0.9999 to 99999)
    Notes
    [42] - No participant analysed for this arm group in this endpoint.
    [43] - No participant analysed for this arm group in this endpoint.
    [44] - No participant analysed for this arm group in this endpoint.
    No statistical analyses for this end point

    Secondary: Time to Response (TTR)

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    End point title
    		 Time to Response (TTR)
    End point description
    TTR: time from first dose of administration until date of first response as assessed by investigator based on Lugano criteria for B-cell NHL and iwCLL for CLL. It is derived for all participants who achieved PR or CR. Detailed definitions of CR and PR as per Lugano and iwCLL criteria in the protocol appendices. The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009. 'Number of subjects analysed’ indicates the number of participants who achieved CR or PR. 9999 indicates that standard deviation was not estimable as there was only 1 participant.
    End point type
    Secondary
    End point timeframe
    From date of first documented CR or PR up to disease progression or death (up to approximately 3 years 4 months)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    0 [45]
    0 [46]
    3
    0 [47]
    1
    3
    2
    1
    Units: months
        arithmetic mean (standard deviation)
    ( )
    ( )
    1.3361 ( 0.1004 )
    ( )
    1.8727 ( 9999 )
    1.2704 ( 0.2138 )
    2.0370 ( 1.0222 )
    1.1828 ( 9999 )
    Notes
    [45] - No participant analysed for this arm group in this endpoint.
    [46] - No participant analysed for this arm group in this endpoint.
    [47] - No participant analysed for this arm group in this endpoint.
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    PFS is defined as the time in days from Day 1 of Cycle 1 to the day of first documented PD, or the day of death due to any cause, whichever comes first as assessed by investigator based on Lugano Criteria for B-cell NHL and iwCLL for CLL. Detailed definitions of PD as per Lugano and iwCLL criteria in the protocol appendices. PFS was estimated using the Kaplan-Meier method. Overall number of subjects analysed=number of participants with data available. 99999= Median and limits of CI were not reached due to less number of participants with events. The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009.
    End point type
    Secondary
    End point timeframe
    From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: months
        median (confidence interval 95%)
    1.4 (1.2 to 99999)
    2.6 (1.3 to 99999)
    4.3 (1.8 to 99999)
    1.2 (1.0 to 4.0)
    2.3 (1.4 to 99999)
    1.9 (0.2 to 3.4)
    99999 (1.3 to 99999)
    0.8 (0.4 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method. The FAS comprises all participants to whom study drug had been assigned and who had received at least 1 dose of GEN3009. Overall number of subjects analysed = number of participants with data available in this outcome measure. 99999 indicates that median and limits of CI not reached due to less number of participants with events.
    End point type
    Secondary
    End point timeframe
    From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    4
    7
    10
    3
    10
    3
    6
    Units: months
        median (confidence interval 95%)
    99999 (19.1 to 99999)
    99999 (5.2 to 99999)
    99999 (1.8 to 99999)
    10.9 (0.8 to 18.0)
    99999 (14.0 to 99999)
    13.7 (0.2 to 99999)
    13.1 (7.0 to 99999)
    6.6 (0.5 to 99999)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR: the percentage of participants who achieved a best overall response (BOR) of CR or PR as assessed by investigator based on Lugano Criteria for B-cell NHL and iwCLL for CLL. Detailed definitions of CR and PR as per Lugano and iwCLL criteria in the protocol appendices. The response evaluable set includes all participants in FAS who have baseline evaluable disease and had at least 1 post-baseline disease evaluation or died within 60 days of first trial treatment. Number of subjects analysed = number of participants with data available in this outcome measure.
    End point type
    Secondary
    End point timeframe
    From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    3
    7
    8
    3
    8
    3
    6
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
    42.9 (9.9 to 81.6)
    0 (0.0 to 36.9)
    33.3 (0.8 to 90.6)
    37.5 (8.5 to 75.5)
    66.7 (9.4 to 99.2)
    16.7 (0.4 to 64.1)
    No statistical analyses for this end point

    Secondary: CR Rate

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    End point title
    		 CR Rate
    End point description
    CR rate was estimated using Clopper-Pearson method. Detailed definitions of CR as per Lugano and iwCLL criteria in the protocol appendices. Overall number of subjects analysed= number of participants with data available in this outcome measure. The Response Evaluable set includes all participants in FAS who have baseline evaluable disease and had at least 1 post-baseline disease evaluation or died within 60 days of first trial treatment.
    End point type
    Secondary
    End point timeframe
    From day of first dose until disease progression or death due to any cause (up to approximately 3 years 4 months)
    End point values
    		 Part 1: GEN3009 Dose Level A in Schedule 1 (S1) Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in Schedule 2 (S2) Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Number of subjects analysed
    3
    3
    7
    8
    3
    8
    3
    6
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
    28.6 (3.7 to 71.0)
    0 (0.0 to 36.9)
    33.3 (0.8 to 90.6)
    0 (0.0 to 36.9)
    33.3 (0.8 to 90.6)
    0 (0.0 to 45.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose until 30 days after the last dose (up to 15.5 months)
    Adverse event reporting additional description
    The Safety analysis set included all participants who had received at least 1 dose of GEN3009.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Part 1: GEN3009 Dose Level A in S1
    Reporting group description
    		 Participants received GEN3009 Dose level A in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level B in S1
    Reporting group description
    		 Participants received GEN3009 Dose level B in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level C in S1
    Reporting group description
    		 Participants received GEN3009 Dose level C in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study.

    Reporting group title
    Part 1: GEN3009 Dose Level D in S1
    Reporting group description
    		 Participants received GEN3009 Dose level D in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group title
    Part 1: GEN3009 Dose Level D in S2
    Reporting group description
    		 Participants received GEN3009 Dose level D in S2 (in US only) by IV infusion on Days 1, 4, 8, 11, 15, 18, 22 and 25 in cycles 1, Day 1, 8, 15 and 22 in Cycles 2-3, Day 1 and 15 in Cycles 4-9 and Day 1 starting Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. Participants received half of the full dose on Days 1, 4, 8, 11, 15, 18, 22, and 25 i.e. two half doses on Days 1 and 4 of each week for the first cycle.

    Reporting group title
    Part 1: GEN3009 Dose Level E in S1
    Reporting group description
    		 Participants received GEN3009 Dose level E in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group title
    Part 1: GEN3009 Dose Level F in S1
    Reporting group description
    		 Participants received GEN3009 Dose level F in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Reporting group title
    Part 1: GEN3009 Dose Level G in S1
    Reporting group description
    		 Participants received GEN3009 Dose level G in S1 by IV infusion on Days 1, 8, 15, and 22 in cycles 1-3, on Days 1 and 15 in cycles 4-9 and on Day 1 (every 4 weeks) in Cycle 10 until disease progression, unacceptable toxicity, death or end of trial. Each cycle was 28 days in this study. For cycle 1, participants received the dose split into 2 consecutive days. i.e., at C1D1 and the remaining amount at C1D2.

    Serious adverse events
    		 Part 1: GEN3009 Dose Level A in S1 Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in S2 Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    4 / 7 (57.14%)
    7 / 10 (70.00%)
    2 / 3 (66.67%)
    4 / 10 (40.00%)
    2 / 3 (66.67%)
    4 / 6 (66.67%)
         number of deaths (all causes)
    1
    1
    3
    8
    1
    6
    2
    3
         number of deaths resulting from adverse events
    0
    0
    2
    0
    0
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    3 / 10 (30.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    3 / 3
    0 / 0
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    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
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Paronychia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    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
    Device related infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    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
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    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
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Part 1: GEN3009 Dose Level A in S1 Part 1: GEN3009 Dose Level B in S1 Part 1: GEN3009 Dose Level C in S1 Part 1: GEN3009 Dose Level D in S1 Part 1: GEN3009 Dose Level D in S2 Part 1: GEN3009 Dose Level E in S1 Part 1: GEN3009 Dose Level F in S1 Part 1: GEN3009 Dose Level G in S1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    7 / 7 (100.00%)
    9 / 10 (90.00%)
    3 / 3 (100.00%)
    10 / 10 (100.00%)
    3 / 3 (100.00%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    2 / 3 (66.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    2
    0
    Flushing
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    Vein disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Phlebitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    5
    0
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Injection site phlebitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    3 / 10 (30.00%)
    0 / 3 (0.00%)
    3 / 10 (30.00%)
    2 / 3 (66.67%)
    2 / 6 (33.33%)
         occurrences all number
    1
    1
    2
    4
    0
    3
    6
    3
    Oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    0
    Feeling jittery
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Infusion site paraesthesia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    Reproductive system and breast disorders
    Scrotal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    2 / 3 (66.67%)
    4 / 6 (66.67%)
         occurrences all number
    0
    0
    1
    2
    0
    1
    4
    4
    Haemoptysis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Hypoxia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Delirium
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    CD4 lymphocytes decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    1
    International normalised ratio increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Vascular access complication
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Scratch
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    7 / 7 (100.00%)
    7 / 10 (70.00%)
    3 / 3 (100.00%)
    10 / 10 (100.00%)
    2 / 3 (66.67%)
    4 / 6 (66.67%)
         occurrences all number
    1
    6
    19
    14
    4
    19
    3
    5
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Anosmia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Meralgia paraesthetica
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Aphasia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    0
    Dizziness postural
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    3
    1
    5
    1
    2
    0
    3
    0
    Coordination abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymph node pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Lymphocytosis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    2 / 3 (66.67%)
    4 / 4 (100.00%)
    7 / 7 (100.00%)
    9 / 10 (90.00%)
    3 / 3 (100.00%)
    7 / 10 (70.00%)
    3 / 3 (100.00%)
    6 / 6 (100.00%)
         occurrences all number
    8
    10
    36
    24
    15
    37
    19
    7
    Anaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    3 / 7 (42.86%)
    4 / 10 (40.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2
    3
    6
    0
    0
    1
    3
    Lymphopenia
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 4 (50.00%)
    3 / 7 (42.86%)
    3 / 10 (30.00%)
    1 / 3 (33.33%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    5
    3
    9
    6
    1
    2
    0
    0
    Leukopenia
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 4 (50.00%)
    2 / 7 (28.57%)
    3 / 10 (30.00%)
    0 / 3 (0.00%)
    4 / 10 (40.00%)
    0 / 3 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    7
    3
    10
    9
    0
    10
    0
    2
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    2
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 4 (75.00%)
    3 / 7 (42.86%)
    6 / 10 (60.00%)
    0 / 3 (0.00%)
    6 / 10 (60.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    10
    9
    0
    6
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Eye disorders
    Scleral haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Refractive amblyopia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Diplopia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Photophobia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Periorbital oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    2 / 3 (66.67%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    1
    Toothache
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    1
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    2 / 10 (20.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    3
    3
    1
    0
    1
    1
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    1
    1
    1
    1
    3
    2
    Dyspepsia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Skin atrophy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    0
    Urinary tract pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    2 / 3 (66.67%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    2
    0
    Bone pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    2
    1
    Muscular weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Bacteraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Rhinovirus infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Candida infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    2
    0
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
    1 / 3 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    1
    1
    0
    Malnutrition
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Decreased appetite
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    2 / 10 (20.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    0
    2
    Steroid diabetes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Hypermagnesaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2021
    - Updated Assessments, section references, and timepoints updated for Dose Escalation and Dose Expansion GEN3009 monotherapy. - Revised to include details of new trial design including the rationale behind the design, dose and schedule rationale for GEN3009 monotherapy and GEN3009 +GEN3013 combination, and end of trial and end of treatment definitions.

    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.
    The trial was terminated due to strategic evaluation of GEN3009 within context of Genmab’s portfolio, decision not based on any safety or regulatory concerns.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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