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    Clinical Trial Results:
    Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa

    Summary
    EudraCT number
    		 2016-002066-32
    Trial protocol
    		 GB   IE   AT   DE   ES   GR   HU   CZ   BE   DK   IT   HR   FR   RO  
    Global end of trial date
    27 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BEB-13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03068780
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amryt Research Limited
    Sponsor organisation address
    45 Mespil Road, Dublin, Ireland, Dublin 4
    Public contact
    Janet Boylan, Amryt Research Limited, 00353 15180200, janet.boylan@amrytpharma.com
    Scientific contact
    Janet Boylan, Amryt Research Limited, 00353 15180200, janet.boylan@amrytpharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001299-PIP03-17
    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
    01 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the double-blind phase was to compare the efficacy of Oleogel-S10 (treatment arm A) with vehicle (treatment arm B) in the promotion of healing of EB partial thickness wounds. This was assessed as evidenced by the incidence of the first complete closure of the EB target wound (defined as EB partial thickness wound of 10 cm2 to 50 cm2 in size aged >=21 days and <9 months in subjects with inherited EB (subtypes DEB, JEB, or Kindler EB) within 45+-7 days of treatment.
    Protection of trial subjects
    Adverse events (AEs) were continuously monitored throughout the study from signing of informed consent until the last follow up assessment. Each AE reported was assessed by a trained Research Physician who ensured that the event was dealt with as appropriate based on clinical need, study protocol and the clinical pharmacology unit (CPU) standard operating procedures (SOPs). The study was conducted by experienced Investigators and well trained medical, nursing and technical staff with ample experience in the conduct of phase 3 clinical trials. The study was designed to closely monitor, treat and communicate potential expected adverse reactions (based on the known mode of action of the IMP and the previous studies with similar compounds) as well as potential unexpected adverse events. Subjects and/or his/her legal representatives had the right to withdraw from the study at any time for any reason without prejudice to their future medical care. Medical information about individual subjects obtained in the course of this study was confidential and could not be disclosed to third parties, except authorized monitors, auditors, or inspectors. In terms of protection of personal data and Ethical considerations, the study protocol complies with the principles of the World Medical Assembly (Helsinki 1964) and subsequent amendments.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Apr 2017
    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
    Brazil: 14
    Country: Number of subjects enrolled
    Chile: 7
    Country: Number of subjects enrolled
    Colombia: 8
    Country: Number of subjects enrolled
    Georgia: 4
    Country: Number of subjects enrolled
    Hong Kong: 2
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Singapore: 2
    Country: Number of subjects enrolled
    Serbia: 19
    Country: Number of subjects enrolled
    Ukraine: 1
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    United States: 14
    Country: Number of subjects enrolled
    Argentina: 39
    Country: Number of subjects enrolled
    Israel: 13
    Worldwide total number of subjects
    223
    EEA total number of subjects
    76
    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)
    8
    Children (2-11 years)
    94
    Adolescents (12-17 years)
    54
    Adults (18-64 years)
    64
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 252 subjects were screened of whom 223 were randomized (109 Oleogel-S10; 114 control gel). 199 completed the Double Blind Phase (DBP) (100 Oleogel-S10; 99 control gel). 6 (all control gel) entered the Open Label Phase (OLP) prematurely. Of the 205 subjects that entered the OLP (100 Oleogel-S10; 105 control gel), 141 completed.

    Pre-assignment
    Screening details
    		 Screening details: All subjects satisfied the inclusion / exclusion criteria based on investigator assessment prior to entry into the study. 29 out of a total of 252 screened patients were reported as screen failures.

    Period 1
    Period 1 title
    Double Blind Phase (DBP)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    An independent unblinded biostatistics team maintained the randomization scheme key in a separate location and was only to distribute this to approved personnel. All randomization materials, including the key, were placed in an unblinded folder with restricted access, which remained restricted until after DBP completion and subsequent locking of the study database for DBP. Subjects or investigators were not unblinded except in an emergency when it was necessary to know the treatment assignment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oleogel-S10
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oleogel-S10
    Investigational medicinal product code
    Other name
    Filsuvez
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The gel was to be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile non-adhesive wound dressing or applied to the dressing so that the gel was in direct contact with the wound. The gel was to be reapplied at each wound dressing change, at least every 4 days.

    Arm title
    		 Control Gel
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Control Gel
    Investigational medicinal product code
    Other name
    Vehicle Gel
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The gel was to be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile non-adhesive wound dressing or applied to the dressing so that the gel was in direct contact with the wound. The gel was to be reapplied at each wound dressing change, at least every 4 days.

    Number of subjects in period 1
    		Oleogel-S10 Control Gel
    Started
    109
    114
    Completed
    100
    99
    Not completed
    9
    15
         Consent withdrawn by subject
    2
    4
         Adverse event, non-fatal
    3
    2
         Other
    4
    9
    Period 2
    Period 2 title
    Open Label Phase (OLP)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Former Oleogel-S10
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oleogel-S10
    Investigational medicinal product code
    Other name
    Filsuvez
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The gel was to be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile non-adhesive wound dressing or applied to the dressing so that the gel was in direct contact with the wound. The gel was to be reapplied at each wound dressing change, at least every 4 days.

    Arm title
    		 Former Control Gel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oleogel-S10
    Investigational medicinal product code
    Other name
    Filsuvez
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The gel was to be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile non-adhesive wound dressing or applied to the dressing so that the gel was in direct contact with the wound. The gel was to be reapplied at each wound dressing change, at least every 4 days.

    Number of subjects in period 2
    		Former Oleogel-S10 Former Control Gel
    Started
    100
    99
    Completed
    66
    75
    Not completed
    34
    30
         Adverse event, serious fatal
    7
    2
         Consent withdrawn by subject
    18
    15
         Adverse event, non-fatal
    2
    5
         Other
    7
    8
    Joined
    0
    6
         Discontinued DBP prematurely and entered OLP
    -
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oleogel-S10
    Reporting group description
    		 -

    Reporting group title
    Control Gel
    Reporting group description
    		 -

    Reporting group values
    		 Oleogel-S10 Control Gel Total
    Number of subjects
    		 109 114 223
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 3 5 8
        Children (2-11 years)
    		 46 48 94
        Adolescents (12-17 years)
    		 25 29 54
        Adults (18-64 years)
    		 33 31 64
        From 65-84 years
    		 2 1 3
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 41 48 89
        Male
    		 68 66 134
    Epidermolysis Bullosa Subtype
    Units: Subjects
        RDEB (recessive dystrophic epidermolysis bullosa)
    		 91 84 175
        DDEB (dominant dystrophic epidermolysis bullosa)
    		 6 14 20
        JEB (junctional epidermolysis bullosa)
    		 11 15 26
        EBS (epidermolysis bullosa simplex)
    		 1 1 2
        Kindler EB
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) included all randomized subjects treated at least once with study medication. Subjects were analyzed according to the randomized treatment regimen (if different from the received treatment). The FAS was used as the primary analysis set for all efficacy analyses.

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set included all subjects treated at least once with study medication. Subjects were analyzed according to the treatment regimen received (if different from the randomized treatment). The Safety Analysis Set was used for all analyses of safety endpoints and the presentation of the study population summaries and subject-level data listings.

    Subject analysis sets values
    		 FAS SAS
    Number of subjects
    223
    223
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    8
    22
        Children (2-11 years)
    94
    80
        Adolescents (12-17 years)
    54
    54
        Adults (18-64 years)
    64
    64
        From 65-84 years
    3
    3
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    89
    89
        Male
    134
    134
    Epidermolysis Bullosa Subtype
    Units: Subjects
        RDEB (recessive dystrophic epidermolysis bullosa)
    175
    175
        DDEB (dominant dystrophic epidermolysis bullosa)
    20
    20
        JEB (junctional epidermolysis bullosa)
    26
    26
        EBS (epidermolysis bullosa simplex)
    2
    2
        Kindler EB
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Oleogel-S10
    Reporting group description
    		 -

    Reporting group title
    Control Gel
    Reporting group description
    		 -
    Reporting group title
    Former Oleogel-S10
    Reporting group description
    		 -

    Reporting group title
    Former Control Gel
    Reporting group description
    		 -

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) included all randomized subjects treated at least once with study medication. Subjects were analyzed according to the randomized treatment regimen (if different from the received treatment). The FAS was used as the primary analysis set for all efficacy analyses.

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set included all subjects treated at least once with study medication. Subjects were analyzed according to the treatment regimen received (if different from the randomized treatment). The Safety Analysis Set was used for all analyses of safety endpoints and the presentation of the study population summaries and subject-level data listings.

    Primary: Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment

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    End point title
    		 Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment
    End point description
    End point type
    Primary
    End point timeframe
    Wound closure within 45 days during the Double Blind Phase
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    109
    114
    Units: Study subjects
    45
    33
    Statistical analysis title
    		 Primary Endpoint Analysis
    Statistical analysis description
    The primary efficacy endpoint was met as the proportion of subjects with first complete closure of the EB target wound within 45 days of initiating treatment was higher in the Oleogel-S10 group (41.3%) compared to the control gel group (28.9%).
    Comparison groups
    Oleogel-S10 v Control Gel
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Cui, Hung, Wang (CHW) approach
    Confidence interval
    Notes
    [1] - P-value was adjusted with the CHW method using CMH test statistics. The CMH test statistics based on a test stratified by EB subtype and target wound size class, were estimated separately for subjects assessed before (Stage 1) and after (Stage 2) the interim analysis for sample size re-estimation. Stagewise normal z-statistics were approximated using the square root of the chi-squared CMH statistics with 1 degree of freedom and pooled to derive the CHW statistic for adjusted p-value calculation.
    [2] - This finding was statistically significant in favor of Oleogel-S10 based on the CHW method using the CMH test statistics (p=0.013).

    Secondary: Time to First Complete Closure of the EB Target Wound as Evidenced by Clinical Assessment Until EDBP (D90±7)

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    End point title
    		 Time to First Complete Closure of the EB Target Wound as Evidenced by Clinical Assessment Until EDBP (D90±7)
    End point description
    The first key secondary endpoint was time to first complete closure of the EB target wound as evidenced by clinical assessment within 90 days using a nonstratified log-rank test. If the primary analysis of the primary efficacy endpoint showed superiority at the 5% significance level, hierarchical confirmatory testing of the 6 key secondary endpoints was to be performed. Because the results for the first key secondary endpoint were not statistically significant, the results for all key secondary endpoints are supportive, rather than confirmatory, thus p-values are not reported.
    End point type
    Secondary
    End point timeframe
    90±7 days
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    109 [3]
    114 [4]
    Units: Days
        Median
    92
    94
    Notes
    [3] - 95% CI: 50.0, not estimable. Difference between the 2 groups not statistically significant, p=0.302
    [4] - 95% CI: 89.0, not estimable. Difference between the 2 groups not statistically significant, p=0.302
    No statistical analyses for this end point

    Secondary: Proportion of Patients With First Complete Closure of the EB Target Wound at D90±7 Based on Clinical Assessment by the Investigator Until Day 90±7.

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    End point title
    		 Proportion of Patients With First Complete Closure of the EB Target Wound at D90±7 Based on Clinical Assessment by the Investigator Until Day 90±7.
    End point description
    The second key secondary endpoint was the proportion of subjects with first complete closure of the EB target wound within 90 days of treatment based on clinical assessment by the investigator.
    End point type
    Secondary
    End point timeframe
    90±7 days
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    109
    114
    Units: Percentage of subjects
    number (not applicable)
        Patients With First Complete Target Wound Closure
    50.5
    43.9
    No statistical analyses for this end point

    Secondary: The Incidence of Target Wound Infection Between Baseline (DBP D0) and D90±7 as Evidenced by AEs and/or Use of Topical and/or Systemic Antibiotics (Related to Wound Infection)

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    End point title
    		 The Incidence of Target Wound Infection Between Baseline (DBP D0) and D90±7 as Evidenced by AEs and/or Use of Topical and/or Systemic Antibiotics (Related to Wound Infection)
    End point description
    The maximum severity of target wound infection between baseline (DBP D0) and D90±7 as evidenced by AEs and/or use of topical and/or systemic antibiotics (related to wound infection) was assessed.
    End point type
    Secondary
    End point timeframe
    90±7 days
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    109
    114
    Units: Patients
        Wound Infection incidence
    1
    5
    No statistical analyses for this end point

    Secondary: The Maximum Severity of Target Wound Infection Between Baseline (DBP D0) and D90±7 as Evidenced by AEs and/or Use of Topical and/or Systemic Antibiotics (Related to Wound Infection)

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    End point title
    		 The Maximum Severity of Target Wound Infection Between Baseline (DBP D0) and D90±7 as Evidenced by AEs and/or Use of Topical and/or Systemic Antibiotics (Related to Wound Infection)
    End point description
    Target wound infections between baseline (DBP D0) and D90±7 were assessed for maximum severity.
    End point type
    Secondary
    End point timeframe
    90±7 days
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    109 [5]
    114 [6]
    Units: Patients with Infected Wounds
        Maximum severity of wound infection: Mild
    1
    0
        Maximum severity of wound infection: Moderate
    0
    3
        Maximum severity of wound infection: Severe
    0
    1
        No wound infection
    108
    110
    Notes
    [5] - Maximum severity was evaluated if a subject had a wound infection event evidenced by adverse events.
    [6] - Maximum severity was evaluated if a subject had a wound infection event evidenced by adverse events.
    No statistical analyses for this end point

    Secondary: Change From Baseline (DBP D0) in Total Body Wound Burden (TBWB) as Evidenced by Clinical Assessment Using Section I (Assessment of the Skin Except for the Anogenital Region) of the 'EB Disease Activity and Scarring Index' (EBDASI) at D90±7

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    End point title
    		 Change From Baseline (DBP D0) in Total Body Wound Burden (TBWB) as Evidenced by Clinical Assessment Using Section I (Assessment of the Skin Except for the Anogenital Region) of the 'EB Disease Activity and Scarring Index' (EBDASI) at D90±7
    End point description
    The evaluation of total body wound burden (TBWB) was based on clinical assessment using Section I of the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI).
    End point type
    Secondary
    End point timeframe
    90±7 days
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    84
    85
    Units: EBDASI skin activity score
    least squares mean (standard error)
        TBWB based on EBDASI score
    -0.44 ( 0.90 )
    -0.56 ( 0.85 )
    No statistical analyses for this end point

    Secondary: Change From Baseline (DBP D0) in Itching Using the 'Itch Man Scale' in Patients ≥ 4 Years and up to 13 Years of Age Before Wound Dressing Changes at D90±7

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    End point title
    		 Change From Baseline (DBP D0) in Itching Using the 'Itch Man Scale' in Patients ≥ 4 Years and up to 13 Years of Age Before Wound Dressing Changes at D90±7
    End point description
    Change from Baseline at Day 90 on Itch Man Scale (patients 4-13 years of age).
    End point type
    Secondary
    End point timeframe
    D90±7
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    39
    43
    Units: Itch Man Scale
        arithmetic mean (standard deviation)
    -0.44 ( 1.31 )
    -1.00 ( 1.31 )
    No statistical analyses for this end point

    Secondary: Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90±7

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    End point title
    		 Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90±7
    End point description
    Change from Baseline at Day 90 on Leuven Itch Scale (patients ≥ 14 years of age).
    End point type
    Secondary
    End point timeframe
    D90±7
    End point values
    		 Oleogel-S10 Control Gel
    Number of subjects analysed
    40 [7]
    37 [8]
    Units: Leuven Itch Scale
    arithmetic mean (standard deviation)
        Frequency subscore
    -8.13 ( 26.18 )
    -10.14 ( 27.3 )
        Duration subscore
    -0.93 ( 35.174 )
    0.98 ( 39.768 )
        Severity subscore
    -4.95 ( 19.33 )
    -10.76 ( 32.68 )
        Consequences subscore
    -4.39 ( 14.073 )
    -3.54 ( 19.402 )
        Distress subscore
    -0.44 ( 22.87 )
    -0.26 ( 34.87 )
        Surface area subscore
    -1.54 ( 12.347 )
    0.68 ( 17.082 )
    Notes
    [7] - No. subjects reported for Frequency. Duration, Severity, Consequences=36 Distress, Surface Area=35
    [8] - No. subjects reported for Frequency. Duration, Severity, Consequences, Distress, Surface Area=34
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Double Blind Phase (DBP) and Open Label Phase (OLP)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Oleogel-S10 (DBP)
    Reporting group description
    		 Oleogel-S10 Double Blind Phase (DBP)

    Reporting group title
    Control Gel (DBP)
    Reporting group description
    		 Control Gel Double Blind Phase (DBP)

    Reporting group title
    Former Oleogel-S10 (OLP)
    Reporting group description
    		 Patients who were in the experimental Oleogel-S10 arm in the DBP before entering the OLP

    Reporting group title
    Former Control Gel (OLP)
    Reporting group description
    		 Patients who were in the Placebo Control Gel arm before entering the OLP

    Serious adverse events
    		 Oleogel-S10 (DBP) Control Gel (DBP) Former Oleogel-S10 (OLP) Former Control Gel (OLP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 109 (6.42%)
    6 / 114 (5.26%)
    26 / 100 (26.00%)
    24 / 105 (22.86%)
         number of deaths (all causes)
    0
    0
    7
    2
         number of deaths resulting from adverse events
    0
    0
    7
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 114 (0.00%)
    3 / 100 (3.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Immune system disorders
    Klebsiella infection
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic congestion
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Eschar
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 114 (0.88%)
    0 / 100 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrostomy tube site complication
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal injury
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Unintentional medical device removal
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Syndactyly
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Talipes
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 109 (2.75%)
    0 / 114 (0.00%)
    4 / 100 (4.00%)
    6 / 105 (5.71%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal stenosis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoperitoneum
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Oesophageal mucosal blister
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    4 / 100 (4.00%)
    6 / 105 (5.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 114 (0.88%)
    0 / 100 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pseudosyndactyly
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    2 / 100 (2.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    2 / 100 (2.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blister infected
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    2 / 100 (2.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related bacteraemia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 114 (0.88%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Pseudomonas infection
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 109 (0.92%)
    2 / 114 (1.75%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    2 / 100 (2.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Skin bacterial infection
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal infection
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 114 (0.88%)
    1 / 100 (1.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    1 / 109 (0.92%)
    1 / 114 (0.88%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 114 (0.88%)
    0 / 100 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    1 / 100 (1.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight gain poor
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    0 / 100 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Oleogel-S10 (DBP) Control Gel (DBP) Former Oleogel-S10 (OLP) Former Control Gel (OLP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 109 (81.65%)
    92 / 114 (80.70%)
    77 / 100 (77.00%)
    81 / 105 (77.14%)
    Injury, poisoning and procedural complications
    Wound complication
    Additional description: Wound complications include increase in wound size vs. baseline or previous visit, wound reopening, wound injury, increase in wound burden, worsening of EB wound pain, wound odor, and wound worsening vs baseline.
         subjects affected / exposed
    67 / 109 (61.47%)
    61 / 114 (53.51%)
    38 / 100 (38.00%)
    46 / 105 (43.81%)
         occurrences all number
    100
    88
    43
    64
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 109 (7.34%)
    4 / 114 (3.51%)
    16 / 100 (16.00%)
    21 / 105 (20.00%)
         occurrences all number
    10
    4
    24
    30
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    9 / 109 (8.26%)
    15 / 114 (13.16%)
    10 / 100 (10.00%)
    10 / 105 (9.52%)
         occurrences all number
    11
    18
    13
    15
    Gastrointestinal disorders
    Oesophageal stenosis
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 114 (0.88%)
    8 / 100 (8.00%)
    11 / 105 (10.48%)
         occurrences all number
    0
    1
    16
    14
    Dysphagia
         subjects affected / exposed
    2 / 109 (1.83%)
    1 / 114 (0.88%)
    6 / 100 (6.00%)
    7 / 105 (6.67%)
         occurrences all number
    2
    1
    8
    9
    Diarrhoea
         subjects affected / exposed
    2 / 109 (1.83%)
    2 / 114 (1.75%)
    3 / 100 (3.00%)
    6 / 105 (5.71%)
         occurrences all number
    2
    2
    3
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 109 (2.75%)
    8 / 114 (7.02%)
    2 / 100 (2.00%)
    1 / 105 (0.95%)
         occurrences all number
    3
    9
    3
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    8 / 109 (7.34%)
    6 / 114 (5.26%)
    5 / 100 (5.00%)
    9 / 105 (8.57%)
         occurrences all number
    8
    7
    5
    13
    Infections and infestations
    Wound infection
         subjects affected / exposed
    8 / 109 (7.34%)
    10 / 114 (8.77%)
    6 / 100 (6.00%)
    15 / 105 (14.29%)
         occurrences all number
    9
    12
    12
    26
    Wound infection staphylococcal
         subjects affected / exposed
    4 / 109 (3.67%)
    3 / 114 (2.63%)
    9 / 100 (9.00%)
    12 / 105 (11.43%)
         occurrences all number
    4
    3
    14
    15
    Wound infection bacterial
         subjects affected / exposed
    3 / 109 (2.75%)
    5 / 114 (4.39%)
    7 / 100 (7.00%)
    9 / 105 (8.57%)
         occurrences all number
    4
    6
    10
    14
    Nasopharyngitis
         subjects affected / exposed
    3 / 109 (2.75%)
    7 / 114 (6.14%)
    3 / 100 (3.00%)
    1 / 105 (0.95%)
         occurrences all number
    3
    7
    3
    2
    Influenza
         subjects affected / exposed
    2 / 109 (1.83%)
    6 / 114 (5.26%)
    1 / 100 (1.00%)
    4 / 105 (3.81%)
         occurrences all number
    2
    6
    4
    4
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 109 (0.00%)
    2 / 114 (1.75%)
    5 / 100 (5.00%)
    5 / 105 (4.76%)
         occurrences all number
    0
    2
    8
    5
    Vitamin D deficiency
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 114 (0.00%)
    4 / 100 (4.00%)
    6 / 105 (5.71%)
         occurrences all number
    0
    0
    4
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2018
    Protocol version 4.0 •A new exclusion criterion was added to exclude subjects with EBS; stratification of randomization was also updated to remove EBS groups. • The definition of an EB target wound was updated to include a maximum wound age of <9 months •The sample size was re-estimated to 192 subjects. • Update to specify children ≥21 days old and <4 years could be included only after confirmation by the IDMC upon review of the safety and bioanalytical data at the interim safety review stage • Update to allow investigator to implement a dose interruption if considered medically necessary for optimal management of the subject • Electrocardiogram assessments were added • Update to allow safety venous blood samples collected at baseline and Day 90 to be used for determination of betulin levels
    01 Oct 2018
    Protocol Version 5.0 • Clarification of the primary endpoint such that the confirmation of closure was no longer included (including statistical analysis). However, the primary endpoint requiring confirmed closure was included as a sensitivity analysis. • Addition of study responsibilities that could be performed by the subject’s parent/legal guardian.
    18 Apr 2019
    Protocol version 6.0 • Based on the results of a planned sample size re-estimation, the IDMC recommended that the sample size be increased by 48 subjects (24 per arm) for a total of 230 evaluable subjects • Certain efficacy endpoints were elevated to the level of “key secondary endpoints” • Instrument for Scoring Clinical Outcome of Research for Epidermolysis Bullosa (iscorEB) added to the efficacy assessments • EuroQol 5 dimensions (EQ-5D) instrument added to the efficacy assessments • Addition of safety laboratory tests at Month 12 • Target wound selection criteria updated to clarify the exclusion of target wounds in the anogenital region

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

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