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    Clinical Trial Results:
    A multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection

    Summary
    EudraCT number
    		 2014-005289-31
    Trial protocol
    		 IT  
    Global end of trial date
    19 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2020
    First version publication date
    24 May 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LF-PB/14/05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02668588
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ND: ND
    Sponsors
    Sponsor organisation name
    Chemi S.p.A.
    Sponsor organisation address
    Via dei Lavoratori 54, Cinisello Balsamo, MI, Italy, 20092
    Public contact
    Clinical Research and Development Director, Chemi S.p.A, +39 02 6443 1, p.bettica@italfarmaco.com
    Scientific contact
    Clinical Research and Development Director, Chemi S.p.A, +39 02 64431, p.bettica@italfarmaco.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
    19 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives were: • To assess the effect of LF-PB 30 mg versus placebo on seroma incidence by Day 28 after ALND. • To assess the safety and tolerability of LF-PB 30 mg.
    Protection of trial subjects
    The trial was conducted in accordance with the Helsinki Declaration and the International Council for Harmonisation (ICH) guidelines on Good Clinical Practice (GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2015
    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
    Italy: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    32
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who signed the inform consent to participate in this trial underwent screening assessments within 3 weeks from Day 0 (randomization/the day of surgery).

    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
    Blinding implementation details
    This was a double-blind study. No further details on the blinding implemetation are reported in the CSR/protocol of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LF-PB 30 mg
    Arm description
    		 LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. LF-PB was supplied as a vial of 10 plus 20 mg sterile freeze-dried octreotide acetate (active product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).
    Arm type
    		 Experimental

    Investigational medicinal product name
    LF-PB
    Investigational medicinal product code
    Other name
    octreotide acetate
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Subjects were dosed once with 30 mg LF-PB administered via gluteus bolus injection. Formulation: Reconstituted active product for i.m. administration. LF-PB 30 mg was supplied as a vial of 10 plus 20 mg sterile freeze-dried octreotide acetate (active product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v)

    Arm title
    		 Placebo
    Arm description
    		 Placebo for LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. Placebo was supplied as a vial of 10 mg sterile freeze-dried soybean lecithin and 5 mg hydroxypropyl-beta-cyclodextrin (placebo product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Subjects were dosed once with placebo for LF-PB 30 mg: administered via gluteus bolus injection. Formulation: reconstituted placebo product for i.m. administration. Placebo for LF-PB 30 mg was supplied as a vial of 10 mg sterile freeze-dried soybean lecithin and 5 mg hydroxypropyl-beta-cyclodextrin (placebo product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).

    Number of subjects in period 1
    		LF-PB 30 mg Placebo
    Started
    24
    24
    Completed
    22
    24
    Not completed
    2
    0
         Consent withdrawn by subject
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LF-PB 30 mg
    Reporting group description
    		 LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. LF-PB was supplied as a vial of 10 plus 20 mg sterile freeze-dried octreotide acetate (active product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. Placebo was supplied as a vial of 10 mg sterile freeze-dried soybean lecithin and 5 mg hydroxypropyl-beta-cyclodextrin (placebo product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).

    Reporting group values
    		 LF-PB 30 mg Placebo Total
    Number of subjects
    		 24 24 48
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 16 17 33
        From 65-84 years
    		 8 7 15
    Gender categorical
    In this study only females aged ≥ 18 years who underwent breast cancer surgery with axillary lymph node dissection were enrolled.
    Units: Subjects
        Female
    		 24 24 48
    Subject analysis sets

    Subject analysis set title
    LF-PB 30 mg - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-treat (ITT) analysis set includes all randomized subjects who receive trial medication and from whom at least one measurement is obtained.

    Subject analysis set title
    Placebo - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-treat (ITT) analysis set includes all randomized subjects who receive trial medication and from whom at least one measurement is obtained.

    Subject analysis set title
    LF-PB 30 mg - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set (SAF) includes all subjects who received 1 dose of LF-PB or placebo will be used to summarize the safety assessments.

    Subject analysis set title
    Placebo - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set (SAF) includes all subjects who received 1 dose of LF-PB or placebo will be used to summarize the safety assessments.

    Subject analysis set title
    LF-PB 30 mg - PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK population: The Pharmacokinetic (PK) analysis set includes all patients who have provided valid and interpretable PK assessments without protocol violation with a probable impact on the pharmacokinetic

    Subject analysis set title
    placebo - PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic (PK) analysis set includes all patients who have provided valid and interpretable PK assessments without protocol violation with a probable impact on the pharmacokinetic

    Subject analysis set title
    LF-PB 30 mg - PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) analysis set will include all subjects who complete the trial without any major deviations related to the assessment of the primary endpoint. Subject will be analysed according to treatment received.

    Subject analysis set title
    placebo - PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) analysis set will include all subjects who complete the trial without any major deviations related to the assessment of the primary endpoint. Subject will be analysed according to treatment received.

    Subject analysis sets values
    		 LF-PB 30 mg - ITT population Placebo - ITT population LF-PB 30 mg - safety population Placebo - safety population LF-PB 30 mg - PK population placebo - PK population LF-PB 30 mg - PP population placebo - PP population
    Number of subjects
    24
    24
    24
    24
    24
    24
    23
    23
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    16
    17
    16
    17
    16
    17
        From 65-84 years
    8
    7
    8
    7
    8
    7
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    In this study only females aged ≥ 18 years who underwent breast cancer surgery with axillary lymph node dissection were enrolled.
    Units: Subjects
        Female
    24
    24
    24
    24
    24
    24

    End points

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    End points reporting groups
    Reporting group title
    LF-PB 30 mg
    Reporting group description
    		 LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. LF-PB was supplied as a vial of 10 plus 20 mg sterile freeze-dried octreotide acetate (active product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. Placebo was supplied as a vial of 10 mg sterile freeze-dried soybean lecithin and 5 mg hydroxypropyl-beta-cyclodextrin (placebo product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).

    Subject analysis set title
    LF-PB 30 mg - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-treat (ITT) analysis set includes all randomized subjects who receive trial medication and from whom at least one measurement is obtained.

    Subject analysis set title
    Placebo - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-treat (ITT) analysis set includes all randomized subjects who receive trial medication and from whom at least one measurement is obtained.

    Subject analysis set title
    LF-PB 30 mg - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set (SAF) includes all subjects who received 1 dose of LF-PB or placebo will be used to summarize the safety assessments.

    Subject analysis set title
    Placebo - safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set (SAF) includes all subjects who received 1 dose of LF-PB or placebo will be used to summarize the safety assessments.

    Subject analysis set title
    LF-PB 30 mg - PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK population: The Pharmacokinetic (PK) analysis set includes all patients who have provided valid and interpretable PK assessments without protocol violation with a probable impact on the pharmacokinetic

    Subject analysis set title
    placebo - PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic (PK) analysis set includes all patients who have provided valid and interpretable PK assessments without protocol violation with a probable impact on the pharmacokinetic

    Subject analysis set title
    LF-PB 30 mg - PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) analysis set will include all subjects who complete the trial without any major deviations related to the assessment of the primary endpoint. Subject will be analysed according to treatment received.

    Subject analysis set title
    placebo - PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) analysis set will include all subjects who complete the trial without any major deviations related to the assessment of the primary endpoint. Subject will be analysed according to treatment received.

    Primary: Incidence of seromas requiring an aspiration by day 28 on ITT population

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    End point title
    		 Incidence of seromas requiring an aspiration by day 28 on ITT population
    End point description
    Incidence of seromas requiring aspiration by Day 28 was calculated as the percentage of subjects who underwent an aspiration of seromas (based on the investigator’s evaluation of the echography at the operated axilla) between discharge or Visit 2 (Day 3) after surgery, and Visit 7 (Day 28). In case of two or more consecutive missing visits the worst-case scenario was assumed.
    End point type
    Primary
    End point timeframe
    by Day 28
    End point values
    		 LF-PB 30 mg - ITT population Placebo - ITT population
    Number of subjects analysed
    24
    24
    Units: percentage
    number (not applicable)
        yes
    75.0
    62.5
        no
    25.0
    37.5
    Statistical analysis title
    		 LF-PB 30 mg vs placebo
    Comparison groups
    LF-PB 30 mg - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.894 [1]
    Method
    		 Fisher exact
    Parameter type
    		 difference in incidence
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 38.5
    Notes
    [1] - One-sided Fisher’s exact test P-value

    Primary: Incidence of seromas requiring an aspiration by day 28 on PP population

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    End point title
    		 Incidence of seromas requiring an aspiration by day 28 on PP population
    End point description
    Incidence of seromas requiring aspiration by Day 28 was calculated as the percentage of subjects who underwent an aspiration of seromas (based on the investigator’s evaluation of the echography at the operated axilla) between discharge or Visit 2 (Day 3) after surgery, and Visit 7 (Day 28). In case of two or more consecutive missing visits the worst-case scenario was assumed.
    End point type
    Primary
    End point timeframe
    By day 28
    End point values
    		 LF-PB 30 mg - PP population placebo - PP population
    Number of subjects analysed
    23
    23
    Units: percentage
    number (not applicable)
        yes
    78.3
    65.2
        no
    21.7
    34.8
    Statistical analysis title
    		 LF-PB 30 mg vs placebo
    Comparison groups
    LF-PB 30 mg - PP population v placebo - PP population
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.905
    Method
    		 Fisher exact
    Parameter type
    		 diffrence in incidence
    Point estimate
    13
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 38.8

    Secondary: Time to resolution of seroma

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    End point title
    		 Time to resolution of seroma
    End point description
    Seroma duration: seroma was considered resolved when at the corresponding visits no aspiration, based on the Investigator clinical evaluation, was required (the information was confirmed at the next visit or at 7 days post ALND, whichever occurred first). If seroma was still present at the end of trial visit, the subject was censored. In case of recurrence of seroma (i.e. recurrence of seroma after the termination of previous one), the final duration was considered the cessation of last episode.
    End point type
    Secondary
    End point timeframe
    At days 1, 3, 7, 11, 14, 21, 28, 56, 84
    End point values
    		 LF-PB 30 mg - ITT population Placebo - ITT population
    Number of subjects analysed
    18
    15
    Units: days
        median (confidence interval 95%)
    15.00 (3.0 to 23.0)
    12.00 (3.00 to 19.00)
    Statistical analysis title
    		 LF-PB 30 mg vs placebo
    Comparison groups
    LF-PB 30 mg - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.534
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 2.79
    Notes
    [2] - Hazard ratio, Confidence Interval and Likelihood Ratio test p-value are derived from Cox-proportional hazards regression model with Treatment as covariate variable

    Secondary: Number of aspirations required

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    End point title
    		 Number of aspirations required
    End point description
    Number of aspirations when volume aspirate was more than zero. In case of recurrent seroma, the number of aspirations was cumulative.
    End point type
    Secondary
    End point timeframe
    At days 3, 7, 11, 14, 21, 28, 56, 84
    End point values
    		 LF-PB 30 mg - ITT population Placebo - ITT population
    Number of subjects analysed
    18
    15
    Units: number
        arithmetic mean (standard deviation)
    3.6 ± 2.50
    4.1 ± 3.33
    Statistical analysis title
    		 LF-PB 30 mg vs placebo
    Comparison groups
    LF-PB 30 mg - ITT population v Placebo - ITT population
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.884
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Total volume of fluid aspirated from seroma

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    End point title
    		 Total volume of fluid aspirated from seroma
    End point description
    Total Volume of Fluid aspirated from seroma after drain removal
    End point type
    Secondary
    End point timeframe
    At days 1, 3, 7, 11, 14, 21, 28, 56, 84
    End point values
    		 LF-PB 30 mg - ITT population Placebo - ITT population
    Number of subjects analysed
    18
    15
    Units: mL
        arithmetic mean (standard deviation)
    461.1 ± 654.96
    445.0 ± 554.13
    No statistical analyses for this end point

    Secondary: Cmax

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    End point title
    		 Cmax
    End point description
    PK samples will be collected pre-dose and 3, 6 and 24 hours post-dose. Samples will also be collected at each scheduled visit until 1 month post-surgery (through Visit 7 – Week 4)
    End point type
    Secondary
    End point timeframe
    Day 0 (surgery), Days 1, 3, 7, 11, 14, 21, 28.
    End point values
    		 LF-PB 30 mg - PK population
    Number of subjects analysed
    24
    Units: ng/mL
        arithmetic mean (standard deviation)
    16.35 ± 8.24
    No statistical analyses for this end point

    Secondary: Tmax

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    End point title
    		 Tmax
    End point description
    PK samples will be collected pre-dose and 3, 6 and 24 hours post-dose. Samples will also be collected at each scheduled visit until 1 month post-surgery (through Visit 7 – Week 4)
    End point type
    Secondary
    End point timeframe
    Day 0 (surgery), Days 1, 3, 7, 11, 14, 21, 28.
    End point values
    		 LF-PB 30 mg - PK population
    Number of subjects analysed
    24
    Units: hour
        arithmetic mean (standard deviation)
    21.17 ± 25.28
    No statistical analyses for this end point

    Secondary: AUClast

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    End point title
    		 AUClast
    End point description
    PK samples will be collected pre-dose and 3, 6 and 24 hours post-dose. Samples will also be collected at each scheduled visit until 1 month post-surgery (through Visit 7 – Week 4)
    End point type
    Secondary
    End point timeframe
    Day 0 (surgery), Days 1, 3, 7, 11, 14, 21, 28.
    End point values
    		 LF-PB 30 mg - PK population
    Number of subjects analysed
    24
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    2229.28 ± 822.39
    No statistical analyses for this end point

    Secondary: T1/2,z

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    End point title
    		 T1/2,z
    End point description
    PK samples will be collected pre-dose and 3, 6 and 24 hours post-dose. Samples will also be collected at each scheduled visit until 1 month post-surgery (through Visit 7 – Week 4)
    End point type
    Secondary
    End point timeframe
    Day 0 (surgery), Days 1, 3, 7, 11, 14, 21, 28.
    End point values
    		 LF-PB 30 mg - PK population
    Number of subjects analysed
    22
    Units: hour
        arithmetic mean (standard deviation)
    97.86 ± 64.23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study, AE data will be obtained at all study visits, based on information spontaneously provided by the patient and/or through questioning
    Adverse event reporting additional description
    An Adverse Event is “any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment”. (ICH E2A)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    LF-PB 30 mg
    Reporting group description
    		 LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. LF-PB was supplied as a vial of 10 plus 20 mg sterile freeze-dried octreotide acetate (active product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for LF-PB 30 mg was administered as a singular intramuscular (i.m.) injection. Placebo was supplied as a vial of 10 mg sterile freeze-dried soybean lecithin and 5 mg hydroxypropyl-beta-cyclodextrin (placebo product) and prefilled syringe of sterile reconstitution solvent (purified soybean lecithin, isopropyl myristate, and ethanol 96% v/v).

    Serious adverse events
    		 LF-PB 30 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LF-PB 30 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 24 (58.33%)
    14 / 24 (58.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm recurrence
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Dry gangrene
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hot flush
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Hypertensive crisis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 24 (16.67%)
    4 / 24 (16.67%)
         occurrences all number
    4
    7
    Injection site pain
         subjects affected / exposed
    3 / 24 (12.50%)
    2 / 24 (8.33%)
         occurrences all number
    3
    2
    Pain
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 24 (4.17%)
         occurrences all number
    3
    1
    Injection site erythema
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Injection site reaction
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Injection site urticaria
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Breast inflammation
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Eschar
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Wound complication
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Wound dehiscence
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Leukopenia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    5 / 24 (20.83%)
    1 / 24 (4.17%)
         occurrences all number
    5
    1
    Diarrhoea
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 24 (4.17%)
         occurrences all number
    3
    1
    Nausea
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Rash erythematous
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Infections and infestations
    Wound infection
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    No limitations or caveats are applicable to this summary of the results
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    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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