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    Clinical Trial Results:
    A Phase I/II Open–Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects with Advanced Solid Tumours

    Summary
    EudraCT number
    		 2018-002732-24
    Trial protocol
    		 FI   GB   NL   FR  
    Global end of trial date
    31 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2025
    First version publication date
    15 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FP2CLI001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03733990
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Faron Pharmaceuticals Ltd
    Sponsor organisation address
    Joukahaisenkatu 6, Turku, Finland, 20520
    Public contact
    Regulatory Affairs, Faron Pharmaceuticals, regulatory.affairs@faron.com
    Scientific contact
    Regulatory Affairs, Faron Pharmaceuticals, regulatory.affairs@faron.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
    13 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To determine the safety, tolerability and recommended dose of FP-1305 in subjects with advanced solid tumours of the selected tumour types without standard treatment options • To determine the safety, tolerability and preliminary efficacy of FP-1305 monotherapy with the objective response rate (ORR), clinical benefit rate (CBR) and immune-related ORR (irORR) in distinct expansion groups of subjects with advanced solid tumours of the selected tumour types • To assess the ORR, CBR and irORR in distinct expansion groups of subjects with advanced solid tumours in CLEVER-1 positive subjects from selected tumour types at a selected dose
    Protection of trial subjects
    Various measures were in place for the protection of trial subjects, which include: Safety assessments prior, during, and post-treatment as per protocol's schedule of events Thorough adverse event reporting Dose modifications List of prohibited interventions (concomitant interventions) Infusion delays Hold of treatment in complete response Management of Toxicities (section 8.9) Contraceptive requirements for males and women of childbearing potential Monitoring pregnancies for potential adverse events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 31
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    United Kingdom: 37
    Country: Number of subjects enrolled
    Finland: 72
    Country: Number of subjects enrolled
    France: 35
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    216
    EEA total number of subjects
    174
    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)
    139
    From 65 to 84 years
    77
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A signed informed consent is available before any screening procedures. During the screening period, a subject’s eligibility for the trial is determined by evaluation of the exclusion and inclusion criteria. Subjects will undergo a medical history review with several parameters assessed (see section 6 of the protocol for more details)

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FP-1305 (Bexmarilimab) 0.1 mg/kg
    Arm description
    		 Part I Dose-escalation FP-1305 0.1 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexmarilimab
    Investigational medicinal product code
    FP-1305
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose was be dependent on treatment arm and was be calculated based on mg/ml, the dose will be administered either Q1W, Q2W, Q3W based on treatment arm and study part

    Arm title
    		 FP-1305 (Bexmarilimab) 0.3 mg/kg
    Arm description
    		 Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexmarilimab
    Investigational medicinal product code
    FP-1305
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose was be dependent on treatment arm and was be calculated based on mg/ml, the dose will be administered either Q1W, Q2W, Q3W based on treatment arm and study part

    Arm title
    		 FP-1305 (Bexmarilimab) 1 mg/kg
    Arm description
    		 Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexmarilimab
    Investigational medicinal product code
    FP-1305
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose was be dependent on treatment arm and was be calculated based on mg/ml, the dose will be administered either Q1W, Q2W, Q3W based on treatment arm and study part

    Arm title
    		 FP-1305 (Bexmarilimab) 3 mg/kg
    Arm description
    		 Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexmarilimab
    Investigational medicinal product code
    FP-1305
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose was be dependent on treatment arm and was be calculated based on mg/ml, the dose will be administered either Q1W, Q2W, Q3W based on treatment arm and study part

    Arm title
    		 FP-1305 (Bexmarilimab) 10 mg/kg
    Arm description
    		 Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexmarilimab
    Investigational medicinal product code
    FP-1305
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose was be dependent on treatment arm and was be calculated based on mg/ml, the dose will be administered either Q1W, Q2W, Q3W based on treatment arm and study part

    Arm title
    		 FP-1305 (Bexmarilimab) 30 mg/kg
    Arm description
    		 Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexmarilimab
    Investigational medicinal product code
    FP-1305
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose was be dependent on treatment arm and was be calculated based on mg/ml, the dose will be administered either Q1W, Q2W, Q3W based on treatment arm and study part

    Number of subjects in period 1
    		FP-1305 (Bexmarilimab) 0.1 mg/kg FP-1305 (Bexmarilimab) 0.3 mg/kg FP-1305 (Bexmarilimab) 1 mg/kg FP-1305 (Bexmarilimab) 3 mg/kg FP-1305 (Bexmarilimab) 10 mg/kg FP-1305 (Bexmarilimab) 30 mg/kg
    Started
    5
    13
    130
    41
    18
    9
    Completed
    5
    13
    130
    41
    18
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FP-1305 (Bexmarilimab) 0.1 mg/kg
    Reporting group description
    		 Part I Dose-escalation FP-1305 0.1 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 0.3 mg/kg
    Reporting group description
    		 Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals

    Reporting group title
    FP-1305 (Bexmarilimab) 1 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 3 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 10 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 30 mg/kg
    Reporting group description
    		 Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group values
    		 FP-1305 (Bexmarilimab) 0.1 mg/kg FP-1305 (Bexmarilimab) 0.3 mg/kg FP-1305 (Bexmarilimab) 1 mg/kg FP-1305 (Bexmarilimab) 3 mg/kg FP-1305 (Bexmarilimab) 10 mg/kg FP-1305 (Bexmarilimab) 30 mg/kg Total
    Number of subjects
    		 5 13 130 41 18 9 216
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 3 3 91 25 9 8 139
        From 65-84 years
    		 2 10 39 16 9 1 77
        85 years and over
    		 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.60 ( 16.950 ) 67.15 ( 5.444 ) 59.67 ( 10.563 ) 61.80 ( 11.023 ) 61.44 ( 13.321 ) 57.33 ( 6.690 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 8 60 19 6 6 104
        Male
    		 0 5 70 22 12 3 112

    End points

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    End points reporting groups
    Reporting group title
    FP-1305 (Bexmarilimab) 0.1 mg/kg
    Reporting group description
    		 Part I Dose-escalation FP-1305 0.1 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 0.3 mg/kg
    Reporting group description
    		 Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals

    Reporting group title
    FP-1305 (Bexmarilimab) 1 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 3 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 10 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 30 mg/kg
    Reporting group description
    		 Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Primary: Dose Limiting Toxicities (DLT) in the Trial Subjects.

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    End point title
    		 Dose Limiting Toxicities (DLT) in the Trial Subjects. [1]
    End point description
    Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.
    End point type
    Primary
    End point timeframe
    up to 1 year
    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: DLT were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 FP-1305 (Bexmarilimab) 0.1 mg/kg FP-1305 (Bexmarilimab) 0.3 mg/kg FP-1305 (Bexmarilimab) 1 mg/kg FP-1305 (Bexmarilimab) 3 mg/kg FP-1305 (Bexmarilimab) 10 mg/kg FP-1305 (Bexmarilimab) 30 mg/kg
    Number of subjects analysed
    5
    13
    130
    41
    18
    9
    Units: DLT
        number (not applicable)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

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    End point title
    		 Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [2]
    End point description
    Number of adverse events and serious adverse events. Adverse events are collected, graded and reported according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
    End point type
    Primary
    End point timeframe
    up to 6 years
    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: TEAE were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 FP-1305 (Bexmarilimab) 0.1 mg/kg FP-1305 (Bexmarilimab) 0.3 mg/kg FP-1305 (Bexmarilimab) 1 mg/kg FP-1305 (Bexmarilimab) 3 mg/kg FP-1305 (Bexmarilimab) 10 mg/kg FP-1305 (Bexmarilimab) 30 mg/kg
    Number of subjects analysed
    5
    13
    130
    41
    18
    9
    Units: subjects
        number (not applicable)
    5
    13
    122
    38
    17
    9
    No statistical analyses for this end point

    Primary: The Response (ORR, CBR and irORR) to the Treatment.

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    End point title
    		 The Response (ORR, CBR and irORR) to the Treatment. [3]
    End point description
    The objective response rate (ORR), clinical benefit rate (CBR) and immune-related ORR (irORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. Results from each tumour type, dose level and dosing frequency will be reported separately.
    End point type
    Primary
    End point timeframe
    up to 6 years
    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: Response were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 FP-1305 (Bexmarilimab) 0.1 mg/kg FP-1305 (Bexmarilimab) 0.3 mg/kg FP-1305 (Bexmarilimab) 1 mg/kg FP-1305 (Bexmarilimab) 3 mg/kg FP-1305 (Bexmarilimab) 10 mg/kg FP-1305 (Bexmarilimab) 30 mg/kg
    Number of subjects analysed
    5
    13
    130
    41
    18
    9
    Units: subjects
    number (not applicable)
        Objective response rate (ORR)
    0
    1
    0
    0
    0
    0
        Disease Control rate (DCR)
    0
    1
    18
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to six years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    FP-1305 (Bexmarilimab) 0.1 mg/kg
    Reporting group description
    		 Part I Dose-escalation FP-1305 0.1 mg/kg is administered in Q3W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 0.3 mg/kg
    Reporting group description
    		 Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals

    Reporting group title
    FP-1305 (Bexmarilimab) 1 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 3 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 10 mg/kg
    Reporting group description
    		 Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Reporting group title
    FP-1305 (Bexmarilimab) 30 mg/kg
    Reporting group description
    		 Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals FP-1305 (bexmarilimab)

    Serious adverse events
    		 FP-1305 (Bexmarilimab) 0.1 mg/kg FP-1305 (Bexmarilimab) 0.3 mg/kg FP-1305 (Bexmarilimab) 1 mg/kg FP-1305 (Bexmarilimab) 3 mg/kg FP-1305 (Bexmarilimab) 10 mg/kg FP-1305 (Bexmarilimab) 30 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 13 (7.69%)
    57 / 130 (43.85%)
    13 / 41 (31.71%)
    10 / 18 (55.56%)
    4 / 9 (44.44%)
         number of deaths (all causes)
    0
    0
    12
    3
    3
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Metastases to central nervous system
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Metastases to meninges
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Metastases to oesophagus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Pericardial effusion malignant
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    Tumour necrosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    12 / 130 (9.23%)
    3 / 41 (7.32%)
    3 / 18 (16.67%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 12
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 12
    0 / 3
    0 / 3
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    4 / 130 (3.08%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    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
    Haemoptysis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Immune-mediated lung disease
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Transaminases increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    3 / 130 (2.31%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Liver function test abnormal
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Spinal fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac tamponade
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    1 / 41 (2.44%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Motor dysfunction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Somnolence
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Pancytopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 13 (0.00%)
    5 / 130 (3.85%)
    2 / 41 (4.88%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 7
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    5 / 130 (3.85%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    3 / 130 (2.31%)
    2 / 41 (4.88%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    2 / 41 (4.88%)
    0 / 18 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    1 / 41 (2.44%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    2 / 130 (1.54%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastric haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    2 / 18 (11.11%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hepatic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Cholangitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Drug Induced Liver Injury
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatic failure
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Immune-mediated hepatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Jaundice
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    2 / 18 (11.11%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenocortical insufficiency acute
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    2 / 41 (4.88%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Myalgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Biliary sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    1 / 41 (2.44%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    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
    Infected seroma
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 13 (0.00%)
    0 / 130 (0.00%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Pyelonephritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia viral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 130 (0.77%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FP-1305 (Bexmarilimab) 0.1 mg/kg FP-1305 (Bexmarilimab) 0.3 mg/kg FP-1305 (Bexmarilimab) 1 mg/kg FP-1305 (Bexmarilimab) 3 mg/kg FP-1305 (Bexmarilimab) 10 mg/kg FP-1305 (Bexmarilimab) 30 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    13 / 13 (100.00%)
    122 / 130 (93.85%)
    38 / 41 (92.68%)
    17 / 18 (94.44%)
    9 / 9 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 13 (0.00%)
    9 / 130 (6.92%)
    4 / 41 (9.76%)
    2 / 18 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    11
    5
    3
    0
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    13 / 130 (10.00%)
    5 / 41 (12.20%)
    2 / 18 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    13
    5
    5
    0
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    3 / 5 (60.00%)
    8 / 13 (61.54%)
    57 / 130 (43.85%)
    16 / 41 (39.02%)
    11 / 18 (61.11%)
    6 / 9 (66.67%)
         occurrences all number
    6
    15
    99
    24
    16
    8
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    1 / 5 (20.00%)
    4 / 13 (30.77%)
    21 / 130 (16.15%)
    4 / 41 (9.76%)
    3 / 18 (16.67%)
    1 / 9 (11.11%)
         occurrences all number
    1
    5
    30
    5
    3
    3
    Investigations
    Investigations
         subjects affected / exposed
    1 / 5 (20.00%)
    4 / 13 (30.77%)
    40 / 130 (30.77%)
    10 / 41 (24.39%)
    6 / 18 (33.33%)
    3 / 9 (33.33%)
         occurrences all number
    1
    10
    104
    22
    18
    7
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 13 (15.38%)
    5 / 130 (3.85%)
    3 / 41 (7.32%)
    1 / 18 (5.56%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    8
    4
    1
    1
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 13 (23.08%)
    14 / 130 (10.77%)
    6 / 41 (14.63%)
    1 / 18 (5.56%)
    6 / 9 (66.67%)
         occurrences all number
    0
    5
    25
    14
    1
    6
    Blood and lymphatic system disorders
    Cardiac disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    3 / 130 (2.31%)
    1 / 41 (2.44%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    7
    1
    1
    0
    Blood and lymphatic disorders
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 13 (15.38%)
    32 / 130 (24.62%)
    11 / 41 (26.83%)
    6 / 18 (33.33%)
    2 / 9 (22.22%)
         occurrences all number
    0
    3
    52
    15
    11
    2
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    2 / 5 (40.00%)
    7 / 13 (53.85%)
    49 / 130 (37.69%)
    20 / 41 (48.78%)
    5 / 18 (27.78%)
    5 / 9 (55.56%)
         occurrences all number
    11
    13
    145
    44
    22
    8
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 13 (15.38%)
    7 / 130 (5.38%)
    3 / 41 (7.32%)
    1 / 18 (5.56%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    16
    4
    1
    0
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    7 / 130 (5.38%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    8
    0
    0
    0
    Endocrine disorders
    Endocrine disorder
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    4 / 130 (3.08%)
    0 / 41 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    3
    4
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    1 / 5 (20.00%)
    5 / 13 (38.46%)
    25 / 130 (19.23%)
    12 / 41 (29.27%)
    5 / 18 (27.78%)
    0 / 9 (0.00%)
         occurrences all number
    2
    10
    47
    18
    8
    0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 13 (15.38%)
    16 / 130 (12.31%)
    7 / 41 (17.07%)
    1 / 18 (5.56%)
    2 / 9 (22.22%)
         occurrences all number
    5
    3
    22
    11
    2
    2
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 13 (23.08%)
    36 / 130 (27.69%)
    10 / 41 (24.39%)
    8 / 18 (44.44%)
    0 / 9 (0.00%)
         occurrences all number
    1
    5
    55
    26
    12
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2018
    Protocol v3.0, 03Dec2018
    05 Sep 2019
    Protocol v5.0, 20Aug2019
    05 Dec 2019
    Protocol v6.0, 28Nov2019
    14 Oct 2020
    Protocol v8.0, 15Sep2020
    23 Jun 2021
    Protocol v10, 09Jun2021
    09 Mar 2022
    Protocol v11, 22Dec2021

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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