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    Clinical Trial Results:
    Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-thymocyte-globulin (ATG) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study

    Summary
    EudraCT number
    		 2005-005719-83
    Trial protocol
    		 DE   IT   ES  
    Global end of trial date
    07 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2022
    First version publication date
    01 May 2022
    Other versions
    Summary report(s)
    		 Medical journal article
    Supplementary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ATG Family Study
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Stem Cell Transplantation, University Medical Center Eppendorf
    Sponsor organisation address
    Martinistraße, 52, Hamburg, Germany, 20246
    Public contact
    Francesca Bonifazi, Institute of Hematology and Clinical Oncology "L. and A. Seràgnoli", +39 0512143853, francesca.bonifazi@unibo.it
    Scientific contact
    Nicolaus Kröger, Bone Marrow Transplantation, University Hospital Hamburg-Eppendorf, +49 40428034850, nkroeger@uke.uni-hamburg.de
    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
    30 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of ATG over Non-ATG in preventing cGvHD after PBSCT, the cumulative incidence of cGvHD in patients with and without ATG administration was compared using competing risk cumulative incidence survival analysis.
    Protection of trial subjects
    Insurance coverage for participating patients is provided by the Randomization and Data Management Office through the insurance companies. For Italy: Gerling Konzern
    Background therapy
    		 Standard GVHD prohylaxis was with Cyclosporine and Methotrexate; the study added in the experimental arm ATG Fresenius, administered ad doses of 10 mg/kg BW on days -3, -2, and -1 before PBSCT via central venous catheter (total cumulative dose: 30 mg/kg BW)
    Evidence for comparator
    		 Cyclosporineand Methotrexate (comparator) was considered the standard option in the EBMT-ELN recommendation (Ruutu T. et al. – Bone Marrow Transplantation 2013)
    Actual start date of recruitment
    16 Nov 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Italy: 99
    Country: Number of subjects enrolled
    Israel: 10
    Worldwide total number of subjects
    161
    EEA total number of subjects
    151
    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)
    161
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male and female patients, 18 – 65 years of age, suffering from ALL or AML in complete remission. Availability of an HLA-identical sibling as a peripheral blood stem cell donor.

    Pre-assignment
    Screening details
    		 Patients with left ventricular ejection fraction < 30 %, Total bilirubin, SGPT or SGOT > 5 times upper the normal level, Creatinine clearance < 30 ml/min, DLCO < 35 % and/or receiving supplementary continuous oxygen.

    Pre-assignment period milestones
    Number of subjects started
    		 161
    Number of subjects completed
    		 161

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment with ATG
    Arm description
    		 Experimental arm adding ATG to the standard GVHD prophylaxis with CSA and MTX
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATG Fresenius
    Investigational medicinal product code
    L04AA03
    Other name
    ANTI-HUMAN – T – LINPHCYTE IMMUNOGLOBULIN SERUM CONCENTRATE
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Administered ad doses of 10 mg/kg BW on days -3, -2, and -1 before PBSC transplant (total cumulative dose: 30 mg/kg BW)

    Investigational medicinal product name
    Busilvex/Busulfan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Busulfan was given at a total dose of 16 mg/kg BW orally or in form of Busilvex® at a dose of 12.8 mg/kg intravenously and it was administered from day -9 to day -6 at a dose of 4 mg/kg BW (orally) or 3.2 mg/kg BW (intravenously) per day. The preferred application of busulfan, however, was Busilvex® intravenously. Busilvex® was administered intravenously via a central venous catheter. The dose of Busilvex® was 0.8 mg/kg of ideal body weight or actual body weight, whichever is lower, administered as a two hour infusion every six hours for four days for a total of 16 doses, starting on day -9 to day -6. For obesive or severely obesive patients Busilvex® was administered based on adjusted ideal body weight.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide at a dose of 120 mg/kg body weight was given intravenously via a central venous catheter on day -4 and -3 at 60 mg/kg BW per day for a total dose of 120 mg/kg BW.

    Investigational medicinal product name
    Mesna
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Mesna to prevent hemorrhagic cystitis was used according to the local practice.

    Investigational medicinal product name
    VP-16 (Etoposide)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Etoposide (VP-16) was given to TBI/Cyclophosphamide or Busulfan/Cyclophosphamide at a dose of 30 - 45 mg/kg, which were given intravenously.

    Investigational medicinal product name
    Cyclosporine A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Cyclosporine A was started at a dose of 3 mg/kg BW per day as continuous infusion, starting on day -1, according to the local standard policy. Cyclosporine A was switched orally, 3 mg/kg b.i.d. when tolerating oral medications, in the absence of GvHD.

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Methotrexate was given on day 1 at a dose of 15 mg/m², and at a dose of 10 mg/m² on day 3, day 6, and day 11 intravenously. In case of severe mucositis and high bilirubin level the dose of methotrexate was adjusted according to the local policy.

    Arm title
    		 Non ATG
    Arm description
    		 Standard arm where patients received the standard GVHD prophylaxis with CSA and MTX
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Busilvex/Busulfan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Busulfan was given at a total dose of 16 mg/kg BW orally or in form of Busilvex® at a dose of 12.8 mg/kg intravenously and it was administered from day -9 to day -6 at a dose of 4 mg/kg BW (orally) or 3.2 mg/kg BW (intravenously) per day. The preferred application of busulfan, however, was Busilvex® intravenously. Busilvex® was administered intravenously via a central venous catheter. The dose of Busilvex® was 0.8 mg/kg of ideal body weight or actual body weight, whichever is lower, administered as a two hour infusion every six hours for four days for a total of 16 doses, starting on day -9 to day -6. For obesive or severely obesive patients Busilvex® was administered based on adjusted ideal body weight.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide at a dose of 120 mg/kg body weight was given intravenously via a central venous catheter on day -4 and -3 at 60 mg/kg BW per day for a total dose of 120 mg/kg BW.

    Investigational medicinal product name
    Mesna
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Mesna to prevent hemorrhagic cystitis was used according to the local practice.

    Investigational medicinal product name
    VP-16 (Etoposide)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Etoposide (VP-16) was given to TBI/Cyclophosphamide or Busulfan/Cyclophosphamide at a dose of 30 - 45 mg/kg, which were given intravenously.

    Investigational medicinal product name
    Cyclosporine A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Cyclosporine A was started at a dose of 3 mg/kg BW per day as continuous infusion, starting on day -1, according to the local standard policy. Cyclosporine A was switched orally, 3 mg/kg b.i.d. when tolerating oral medications, in the absence of GvHD.

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Methotrexate was given on day 1 at a dose of 15 mg/m², and at a dose of 10 mg/m² on day 3, day 6, and day 11 intravenously. In case of severe mucositis and high bilirubin level the dose of methotrexate was adjusted according to the local policy.

    Number of subjects in period 1
    		Treatment with ATG Non ATG
    Started
    86
    75
    Completed
    83
    72
    Not completed
    3
    3
         Leukemia relapse
    3
    1
         Consent withdrawn by donor
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment with ATG
    Reporting group description
    		 Experimental arm adding ATG to the standard GVHD prophylaxis with CSA and MTX

    Reporting group title
    Non ATG
    Reporting group description
    		 Standard arm where patients received the standard GVHD prophylaxis with CSA and MTX

    Reporting group values
    		 Treatment with ATG Non ATG Total
    Number of subjects
    		 86 75 161
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 86 75 161
    Age continuous
    Units: years
        median (full range (min-max))
    		 39 (18 to 64) 43.5 (21 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 32 33 65
        Male
    		 54 42 96
    Baseline Characteristics of the Participiants
    Units: Subjects
        First complete remission at transplantation
    		 73 66 139
        Second complete remission at transplantation
    		 10 6 16
        Excluded patients
    		 3 3 6
    Subject analysis sets

    Subject analysis set title
    Randomized and treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized and treated patients

    Subject analysis sets values
    		 Randomized and treated patients
    Number of subjects
    155
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    155
    Age continuous
    Units: years
        median (full range (min-max))
    41.25 (18 to 64)
    Gender categorical
    Units: Subjects
        Female
    62
        Male
    93
    Baseline Characteristics of the Participiants
    Units: Subjects
        First complete remission at transplantation
    139
        Second complete remission at transplantation
    16
        Excluded patients
    0

    End points

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    End points reporting groups
    Reporting group title
    Treatment with ATG
    Reporting group description
    		 Experimental arm adding ATG to the standard GVHD prophylaxis with CSA and MTX

    Reporting group title
    Non ATG
    Reporting group description
    		 Standard arm where patients received the standard GVHD prophylaxis with CSA and MTX

    Subject analysis set title
    Randomized and treated patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized and treated patients

    Primary: Cumulative Incidence of cGVHD

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    End point title
    		 Cumulative Incidence of cGVHD
    End point description
    Comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic peripheral blood stem cell transplantation from HLA-identical siblings with or without antithymocyte globulin according to the revised Seattle criteria of Lee et al.
    End point type
    Primary
    End point timeframe
    The primary endpoint of the study was the cumulative incidence of chronic GVHD at 2 years.
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: Patients
    24
    9
    Statistical analysis title
    		 Cumulative incidence analyses
    Statistical analysis description
    Cumulative incidence analyses were performed with the use of NCSS statistical software, version 9, and R statistical software, version 2.10.1 (cmprsk package)
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Relapse

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    End point title
    		 Relapse
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: Patients
    33
    35
    Statistical analysis title
    		 Relapse analysis
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Relapse-free Survival

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    End point title
    		 Relapse-free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: Patients
    33
    35
    Statistical analysis title
    		 Relapse-free Survival analysis
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: Patients
    36
    35
    Statistical analysis title
    		 Overall Survival analysis
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Non relapse-Related Death

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    End point title
    		 Non relapse-Related Death
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: Patients
    36
    36
    Statistical analysis title
    		 Non relapse-Related Death
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Chronic GVHD–free + Relapse free Survival

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    End point title
    		 Chronic GVHD–free + Relapse free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: Patients
    22
    8
    Statistical analysis title
    		 Chronic GVHD–free + Relapse free Survival
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Leucocytes engrafment

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    End point title
    		 Leucocytes engrafment
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: days
        median (full range (min-max))
    18 (10 to 31)
    15 (11 to 34)
    Statistical analysis title
    		 Leucocytes engrafment analysis
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Platelet engrafment

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    End point title
    		 Platelet engrafment
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: days
        median (full range (min-max))
    20 (10 to 110)
    13 (6 to 29)
    Statistical analysis title
    		 Platelet engrafment analysis
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Acute GVHD

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    End point title
    		 Acute GVHD
    End point description
    End point type
    Secondary
    End point timeframe
    100 days
    End point values
    		 Treatment with ATG Non ATG
    Number of subjects analysed
    83
    72
    Units: Patients
    21
    25
    Statistical analysis title
    		 Acute GVHD analysis
    Comparison groups
    Treatment with ATG v Non ATG
    Number of subjects included in analysis
    155
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Report period (any causal relationship to ATG-Fresenius S), by MedDRA System Organ Classes and Preferred Terms (all randomized patients).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Treatment with ATG
    Reporting group description
    		 Randomized and allocated in experimental arm where patients have been treated adding ATG to the standard GVHD prophylaxis with CSA and MTX

    Reporting group title
    NON-ATG
    Reporting group description
    		 Randomized, treated and allocated to comparator arm where patients received the standard GVHD prophylaxis with CSA and MTX

    Serious adverse events
    		 Treatment with ATG NON-ATG
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 83 (9.64%)
    4 / 72 (5.56%)
         number of deaths (all causes)
    1
    3
         number of deaths resulting from adverse events
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Leukaemia recurrent
         subjects affected / exposed
    3 / 83 (3.61%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Mastectomy
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Myelitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4.77%
    Non-serious adverse events
    		 Treatment with ATG NON-ATG
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 83 (73.49%)
    72 / 72 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 72 (0.00%)
         occurrences all number
    3
    0
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    1 / 83 (1.20%)
    5 / 72 (6.94%)
         occurrences all number
    1
    7
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    6 / 83 (7.23%)
    13 / 72 (18.06%)
         occurrences all number
    7
    21
    Immune system disorders
    Immune system disorders
         subjects affected / exposed
    3 / 83 (3.61%)
    3 / 72 (4.17%)
         occurrences all number
    3
    3
    Reproductive system and breast disorders
    Reproductive system and breast disorders
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    4 / 83 (4.82%)
    4 / 72 (5.56%)
         occurrences all number
    4
    7
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Investigations
    Investigations
         subjects affected / exposed
    0 / 83 (0.00%)
    2 / 72 (2.78%)
         occurrences all number
    0
    8
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    1 / 83 (1.20%)
    6 / 72 (8.33%)
         occurrences all number
    1
    6
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    1 / 83 (1.20%)
    4 / 72 (5.56%)
         occurrences all number
    1
    6
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    4 / 83 (4.82%)
    4 / 72 (5.56%)
         occurrences all number
    16
    6
    Eye disorders
    Eye disorders
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    3 / 83 (3.61%)
    9 / 72 (12.50%)
         occurrences all number
    6
    15
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    10 / 83 (12.05%)
    5 / 72 (6.94%)
         occurrences all number
    12
    7
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    3 / 83 (3.61%)
    4 / 72 (5.56%)
         occurrences all number
    3
    4
    Endocrine disorders
    Endocrine disorders
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    2 / 83 (2.41%)
    2 / 72 (2.78%)
         occurrences all number
    2
    3
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    16 / 83 (19.28%)
    14 / 72 (19.44%)
         occurrences all number
    22
    34
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    1 / 83 (1.20%)
    4 / 72 (5.56%)
         occurrences all number
    1
    8

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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.
    None reported
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    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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