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    Clinical Trial Results:
    Thiotepa- Fludarabine- Treosulfan (TFT) conditioning for 2nd allogeneic PBSCT from a different unrelated donor in patients with AML relapsing from prior allogeneic HCT Konditionierung mit Thiotepa-Fludarabin-Treosulfan (TFT) bei zweiter allogener Stammzelltranplantation von einem anderen nicht verwandten Spender für Patienten mit Rezidiv einer AML nach 1. allogener Stammzelltransplantation

    Summary
    EudraCT number
    		 2012-005414-18
    Trial protocol
    		 DE  
    Global end of trial date
    17 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2022
    First version publication date
    14 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZKS000783
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00005126
    Sponsors
    Sponsor organisation name
    Medical Center - University of Freiburg
    Sponsor organisation address
    Breisacher Str. 153, Freiburg, Germany, 79110
    Public contact
    Dr. med. Olga Grichina, Clinical Trials Unit, Medical Center - University of Freiburg, +49 761270-74410, olga.grichina@uniklinik-freiburg.de
    Scientific contact
    Prof. Dr. med. Jürgen Finke, Department of Medicine I, Medical Center - University of Freiburg, +49 761270-33640, juergen.finke@uniklinik-freiburg.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
    13 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the probability of disease-free survival (DFS), defined as being alive and free of relapse at 1 year after 2nd allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT, 2nd Tx) from unrelated donors after a uniform "intensive-RIC" conditioning with the TFT regimen and defined Graft-versus-Host-Disease (GvHD) prophylaxis
    Protection of trial subjects
    The clinical trial was designed in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC), and with the ethical principles laid down in the Declaration of Helsinki. The protocol and the proposed informed consent form was reviewed and approved by a properly constituted Independent Ethics Committee (IEC of the University of Freiburg) before trial start.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Mar 2014
    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
    Germany: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    50
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 52 patients were registered for the study from 25th March 2014 up to 10th March 2017 from 9 German centres

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 52
    Number of subjects completed
    		 52

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 2nd alloHC after conditioning regimen and GvHD propyhlaxis
    Arm description
    		 2nd allogenic peripheral blood hematopoietic cell transplantation (HCT) from an unrelated donor after a uniform conditioning with Treosulfan 3x12g/m2, Fludarabin 3x30mg/m2, and Thiotepa 3x 5mg/kg (TFT), and Graft versus Host Disease (GvHD) prophylaxis with cyclosporine A (CyA) /Mycophenolate and ATG-F (Neovii) 3x10mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Thiotepa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3x 5 mg/kg

    Investigational medicinal product name
    Treosulfan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3x12 g/m2

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3x30 mg/m2

    Number of subjects in period 1
    		2nd alloHC after conditioning regimen and GvHD propyhlaxis
    Started
    52
    Completed
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 52 52
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 50 50
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.9 ( 12.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 33 33
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all patients registered for the study, for whom the conditioning regimen TFT and the GvHD prophylaxis regimen Cyclosporine A (CyA), Mycophenolic Acid (MPA) / Mycophenolate mofetil (MMF), ATG-F has started, and for whom allogeneic PBSCT from an unrelated donor has been performed.

    Subject analysis sets values
    		 FAS
    Number of subjects
    50
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    48
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.6 ( 12.1 )
    Gender categorical
    Units: Subjects
        Female
    18
        Male
    32

    End points

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    End points reporting groups
    Reporting group title
    2nd alloHC after conditioning regimen and GvHD propyhlaxis
    Reporting group description
    		 2nd allogenic peripheral blood hematopoietic cell transplantation (HCT) from an unrelated donor after a uniform conditioning with Treosulfan 3x12g/m2, Fludarabin 3x30mg/m2, and Thiotepa 3x 5mg/kg (TFT), and Graft versus Host Disease (GvHD) prophylaxis with cyclosporine A (CyA) /Mycophenolate and ATG-F (Neovii) 3x10mg/kg.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all patients registered for the study, for whom the conditioning regimen TFT and the GvHD prophylaxis regimen Cyclosporine A (CyA), Mycophenolic Acid (MPA) / Mycophenolate mofetil (MMF), ATG-F has started, and for whom allogeneic PBSCT from an unrelated donor has been performed.

    Primary: Disease-free survival (DFS)

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    End point title
    		 Disease-free survival (DFS) [1]
    End point description
    Defined as being alive and free of relapse at 12 months post 2nd Tx.
    End point type
    Primary
    End point timeframe
    12 months post 2nd Tx
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Single-arm phase II trial, comparison with historical control data.
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probabilty of DFS
        number (confidence interval 95%)
    0.46 (0.318 to 0.607)
    No statistical analyses for this end point

    Secondary: Relapse

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    End point title
    		 Relapse
    End point description
    Probability of relapse at 36 months after 2nd TX
    End point type
    Secondary
    End point timeframe
    36 months after 2nd TX
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability of relapse
        number (confidence interval 95%)
    0.36 (0.25 to 0.52)
    No statistical analyses for this end point

    Secondary: Relapse mortality

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    End point title
    		 Relapse mortality
    End point description
    Probability of relapse mortality at 36 months after 2nd TX
    End point type
    Secondary
    End point timeframe
    36 months after 2nd TX
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.35 (0.24 to 0.51)
    No statistical analyses for this end point

    Secondary: Non-relapse mortality

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    End point title
    		 Non-relapse mortality
    End point description
    Probability of non-relapse mortality at 36 months after 2nd TX
    End point type
    Secondary
    End point timeframe
    36 months after 2nd TX
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probabilty
        number (confidence interval 95%)
    0.40 (0.29 to 0.57)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Probability of overall survival at 36 months after 2nd TX
    End point type
    Secondary
    End point timeframe
    36 months after 2nd TX
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.24 (0.13 to 0.37)
    No statistical analyses for this end point

    Secondary: Acute graft versus host disease (aGvHD) any

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    End point title
    		 Acute graft versus host disease (aGvHD) any
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.54 (0.42 to 0.70)
    No statistical analyses for this end point

    Secondary: Acute graft versus host disease (aGvHD) Grade II-IV

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    End point title
    		 Acute graft versus host disease (aGvHD) Grade II-IV
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.42 (0.30 to 0.58)
    No statistical analyses for this end point

    Secondary: Acute graft versus host disease (aGvHD) Grade III-IV

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    End point title
    		 Acute graft versus host disease (aGvHD) Grade III-IV
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.26 (0.16 to 0.42)
    No statistical analyses for this end point

    Secondary: Chronic graft versus host disease (cGvHD) any

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    End point title
    		 Chronic graft versus host disease (cGvHD) any
    End point description
    End point type
    Secondary
    End point timeframe
    12 months post 2nd TX
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.26 (0.16 to 0.42)
    No statistical analyses for this end point

    Secondary: Chronic graft versus host disease (cGvHD) extensive (Seattle)

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    End point title
    		 Chronic graft versus host disease (cGvHD) extensive (Seattle)
    End point description
    Probability of extensive (Seattle) chronic GvHD at 12 months post 2nd TX
    End point type
    Secondary
    End point timeframe
    12 months post 2nd TX
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.20 (0.12 to 0.35)
    No statistical analyses for this end point

    Secondary: Chronic graft versus host disease (cGvHD) moderate/severe (NIH)

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    End point title
    		 Chronic graft versus host disease (cGvHD) moderate/severe (NIH)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months post 2nd TX
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.22 (0.13 to 0.37)
    No statistical analyses for this end point

    Secondary: ECOG performance status

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    End point title
    		 ECOG performance status
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 FAS
    Number of subjects analysed
    26
    Units: Number of patients
        Grade 0
    7
        Grade 1
    16
        Grade 2
    1
        Grade 3
    0
        Grade 4
    0
        Grade 5
    0
        Missing
    2
    No statistical analyses for this end point

    Secondary: Engraftment (ANC>0.5/nL)

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    End point title
    		 Engraftment (ANC>0.5/nL)
    End point description
    End point type
    Secondary
    End point timeframe
    at 3 months and at 6 months
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.94 (0.87 to 1.00)
    No statistical analyses for this end point

    Secondary: Engraftment (ANC>1.0/nL)

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    End point title
    		 Engraftment (ANC>1.0/nL)
    End point description
    End point type
    Secondary
    End point timeframe
    at 3 months and at 6 months
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.92 (0.85 to 1.00)
    No statistical analyses for this end point

    Secondary: Platelet engraftment (platelets>20/nL)

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    End point title
    		 Platelet engraftment (platelets>20/nL)
    End point description
    Probability of engraftment (platelets >20/nL)
    End point type
    Secondary
    End point timeframe
    at 3 months and 6 months
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.80 (0.70 to 0.92)
    No statistical analyses for this end point

    Secondary: Platelet engraftment (platelets>100/nL)

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    End point title
    		 Platelet engraftment (platelets>100/nL)
    End point description
    Probability of engraftment (platelets >100/nL)
    End point type
    Secondary
    End point timeframe
    at 3 months and at 6 months
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: Probability
        number (confidence interval 95%)
    0.62 (0.50 to 0.77)
    No statistical analyses for this end point

    Secondary: Disease-free survival (DSF)

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    End point title
    		 Disease-free survival (DSF)
    End point description
    Median DFS time post 2nd Tx, defined as time from 2nd Tx until relapse or death.
    End point type
    Secondary
    End point timeframe
    Time from 2nd Tx until relapse or death
    End point values
    		 FAS
    Number of subjects analysed
    50
    Units: DSF time
        median (confidence interval 95%)
    8.69 (2.76 to 32.16)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Complete study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 2nd alloHC after conditioning regimen and GvHD propyhlaxis

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 52 (55.77%)
         number of deaths (all causes)
    39
         number of deaths resulting from adverse events
    15
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory failure
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral toxoplasmosis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Febrile infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Herpes zoster
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster meningoencephalitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Metapneumovirus infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Oesophageal infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 52 (11.54%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    1 / 4
    Pulmonary sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    7 / 52 (13.46%)
         occurrences causally related to treatment / all
    4 / 7
         deaths causally related to treatment / all
    2 / 5
    Septic shock
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    1 / 2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral haemorrhagic cystitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 52 (100.00%)
    Vascular disorders
    Capillary leak syndrome
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    15 / 52 (28.85%)
         occurrences all number
    15
    Hypotension
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Venoocclusive disease
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Extravasation
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    6 / 52 (11.54%)
         occurrences all number
    6
    Localised oedema
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Mucosal haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Mucosal inflammation
         subjects affected / exposed
    32 / 52 (61.54%)
         occurrences all number
    32
    Oedema peripheral
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    9
    Oedema
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    8
    Pain
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    17 / 52 (32.69%)
         occurrences all number
    20
    Immune system disorders
    Allergic reaction to excipient
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Hypersensitivity
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Cough
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Dysphonia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    8
    Hypoxia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Interstitial lung disease
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Obstructive airways disorder
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pleural effusion
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Respiratory failure
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Hallucination
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Intentional self-injury
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Organic brain syndrome
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Product issues
    Liquid product physical issue
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Biopsy soft tissue
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood albumin decreased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood bilirubin increased
         subjects affected / exposed
    14 / 52 (26.92%)
         occurrences all number
    24
    Blood calcium decreased
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Blood cholinesterase decreased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    10 / 52 (19.23%)
         occurrences all number
    16
    Blood culture positive
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood immunoglobulin G decreased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Blood magnesium decreased
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Blood urea increased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    7 / 52 (13.46%)
         occurrences all number
    8
    Haemoglobin decreased
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Liver function test increased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Thyroxine free decreased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Troponin T increased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Tri-iodothyronine free decreased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    4
    White blood cell count decreased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Transfusion-related acute lung injury
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Atrial fibrillation
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Cardiac failure
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pericardial effusion
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Sinus tachycardia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Tachycardia
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cerebral ischaemia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Encephalopathy
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    6
    Myoclonus
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Seizure
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Syncope
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 52 (17.31%)
         occurrences all number
    11
    Coagulopathy
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Febrile neutropenia
         subjects affected / exposed
    12 / 52 (23.08%)
         occurrences all number
    12
    Haemolysis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Leukopenia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Pancytopenia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    11 / 52 (21.15%)
         occurrences all number
    12
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Lacrimation increased
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pupils unequal
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    7 / 52 (13.46%)
         occurrences all number
    7
    Anal haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Ascites
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Colitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    6 / 52 (11.54%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    29 / 52 (55.77%)
         occurrences all number
    32
    Duodenitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Haematemesis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Ileus
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Large intestinal stenosis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Lip disorder
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Mouth haemorrhage
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    37 / 52 (71.15%)
         occurrences all number
    43
    Neutropenic colitis
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Oral blood blister
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Oesophagitis
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    3
    Proctalgia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Subileus
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    19 / 52 (36.54%)
         occurrences all number
    21
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Hydrocholecystis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Liver disorder
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Decubitus ulcer
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Drug eruption
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Petechiae
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    16 / 52 (30.77%)
         occurrences all number
    17
    Rash maculo-papular
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Skin fissures
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Skin lesion
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Bladder spasm
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Dysuria
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Pollakiuria
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Muscle spasms
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    2
    Myalgia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Anal abscess
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    BK virus infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Atypical pneumonia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Bacterial infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Bacterial sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Candida infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Clostridium difficile colitis
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Coronavirus infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cystitis bacterial
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    8 / 52 (15.38%)
         occurrences all number
    8
    Device related infection
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Enterococcal sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Enterobacter infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Epstein-Barr virus infection reactivation
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Eye infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Escherichia sepsis
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Fusarium infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Herpes simplex
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Herpes simplex reactivation
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Human herpesvirus 6 infection reactivation
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4
    Klebsiella infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Pneumonia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pulmonary mycosis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Relapsing fever
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Soft tissue infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Staphylococcal infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    9 / 52 (17.31%)
         occurrences all number
    9
    Vascular device infection
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    Hyperkalaemia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Hypernatraemia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Hypocalcaemia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    11 / 52 (21.15%)
         occurrences all number
    13
    Hyponatraemia
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    5
    Hypophosphataemia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Hypoproteinaemia
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Hypomagnesaemia
         subjects affected / exposed
    7 / 52 (13.46%)
         occurrences all number
    7

    More information

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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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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