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    Clinical Trial Results:
    Prospective, open-label, randomised, two-arm, controlled, multicentre clinical trial, phase I/IIa, for the evaluation of safety and efficacy of an adoptive immunotherapy with allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for the prevention or treatment of reactivation of 'CMV and/or EBV in patients after allogeneic HLA-identical stem cell transplantation

    Summary
    EudraCT number
    		 2012-004240-30
    Trial protocol
    		 DE  
    Global end of trial date
    26 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2020
    First version publication date
    03 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AIT-MULTIVIR-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Maximiliansplatz 2, Erlangen, Germany, 91054
    Public contact
    Direktion Medizinische Klinik 5, Medizinische Klinik 5, Universitätsklinikum Erlangen, +49 09131 85 35954, andreas.mackensen@uk-erlangen.de
    Scientific contact
    Direktion Medizinische Klinik 5, Medizinische Klinik 5, Universitätsklinikum Erlangen, +49 09131 85 35954, andreas.mackensen@uk-erlangen.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
    26 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluation of the safety and tolerability of an adoptive immunotherapy with CMV-/EBV-specific peptide-stimulated T-cells (CD3+) for prevention or treatment of the reactivation of CMV or EBV infection in patients after allogeneic HLA-identical stem cell transplantation.
    Protection of trial subjects
    IMP sterility and purity testing, Premedication with antihistaminics, cardiopulmonal Monitoring
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2014
    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
    Germany: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    23
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening and randomization -> SCT -> Eligibility check Prior to IMP Administration -> final enrollment -> IMP admin. (Verum)/watch and wait (Control)

    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum1
    Arm description
    		 Subjects randomized to IMP
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20.000 - 50.000 cells per kg BW, 3 applications (day 1/30/60 = day 30/60/90 after stem cell Transplantation)

    Arm title
    		 Control1
    Arm description
    		 Subjects randomized to Control
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Verum1 Control1
    Started
    16
    13
    Completed
    16
    13
    Period 2
    Period 2 title
    Pre-Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum2
    Arm description
    		 Subjects randomized to IMP who passed eligibility Evaluation (V2) and for whom IMP could be produced
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20.000 - 50.000 cells per kg BW, 3 applications (day 1/30/60 = day 30/60/90 after stem cell Transplantation)

    Arm title
    		 Control2
    Arm description
    		 Subjects randomized to Control plus subjects randomized to Verum but IMP could not be produced
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Verum2 Control2
    Started
    16
    13
    Completed
    9
    16
    Not completed
    7
    0
         Consent withdrawn by subject
    2
    -
         Physician decision
    2
    -
         Transferred to other arm/group
    3
    -
    Joined
    0
    3
         Transferred in from other group/arm
    -
    3
    Period 3
    Period 3 title
    Treatment and Follow up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum3
    Arm description
    		 Subjects with at least one IMP administered
    Arm type
    		 Experimental

    Investigational medicinal product name
    Allogeneic CMV-/EBV-specific peptide-stimulated T-cells (CD3+)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20.000 - 50.000 cells per kg BW, 3 applications (day 1/30/60 = day 30/60/90 after stem cell Transplantation)

    Arm title
    		 Control3
    Arm description
    		 Subjects from Control2 who reached EoS (day 204)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Verum3 Control3
    Started
    9
    16
    Completed
    9
    14
    Not completed
    0
    2
         Adverse event, non-fatal
    -
    1
         Relaps underlying disease (AML)
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Verum1
    Reporting group description
    		 Subjects randomized to IMP

    Reporting group title
    Control1
    Reporting group description
    		 Subjects randomized to Control

    Reporting group values
    		 Verum1 Control1 Total
    Number of subjects
    		 16 13 29
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 57.2 (29 to 75) 56.3 (25 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 3 1 4
        Male
    		 13 12 25

    End points

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    End points reporting groups
    Reporting group title
    Verum1
    Reporting group description
    		 Subjects randomized to IMP

    Reporting group title
    Control1
    Reporting group description
    		 Subjects randomized to Control
    Reporting group title
    Verum2
    Reporting group description
    		 Subjects randomized to IMP who passed eligibility Evaluation (V2) and for whom IMP could be produced

    Reporting group title
    Control2
    Reporting group description
    		 Subjects randomized to Control plus subjects randomized to Verum but IMP could not be produced
    Reporting group title
    Verum3
    Reporting group description
    		 Subjects with at least one IMP administered

    Reporting group title
    Control3
    Reporting group description
    		 Subjects from Control2 who reached EoS (day 204)

    Primary: Occurrence of acute toxicity

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    End point title
    		 Occurrence of acute toxicity [1]
    End point description
    e.g. allergic or anaphylactic reaction CTCAE>= 2
    End point type
    Primary
    End point timeframe
    within 72 Hours after Administration of the IMP
    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: Toxicity could occur only in Verum Group (Control: no IMP given); as no toxicity was reported, no statistical Analysis necessary
    End point values
    		 Verum3
    Number of subjects analysed
    9
    Units: events
    0
    No statistical analyses for this end point

    Primary: De novo onset of acute GvHD within 14 days after administration of the IMP

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    End point title
    		 De novo onset of acute GvHD within 14 days after administration of the IMP [2]
    End point description
    End point type
    Primary
    End point timeframe
    at all visits during Treatment and follow up period
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Acute GvHD within 14 days after IMP administration could occur only in Verum Group (Control: no IMP given); as no Acute GvHD within 14 days after IMP administration was reported, no statistical Analysis necessary
    End point values
    		 Verum3
    Number of subjects analysed
    9
    Units: events
    0
    No statistical analyses for this end point

    Primary: Occurrence of an aggravation of pre-existing acute GvHD (persistent acute GvHD) within 14 days after administratin of the IMP

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    End point title
    		 Occurrence of an aggravation of pre-existing acute GvHD (persistent acute GvHD) within 14 days after administratin of the IMP [3]
    End point description
    End point type
    Primary
    End point timeframe
    at all visits during Treatment and follow-up period
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Endpoint could occur only in Verum Group (Control: no IMP given); as no Aggravation of a pre-existing acute GvHD was reported, no statistical Analysis necessary
    End point values
    		 Verum3
    Number of subjects analysed
    9
    Units: events
    0
    No statistical analyses for this end point

    Primary: Occurrence of at least one CMV reactivation

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    End point title
    		 Occurrence of at least one CMV reactivation
    End point description
    End point type
    Primary
    End point timeframe
    at all visits during the Treatment and follow-up period
    End point values
    		 Verum3 Control3
    Number of subjects analysed
    9
    14
    Units: event
    4
    9
    Attachments
    		 Cum incid CMV reactivation
    Statistical analysis title
    		 CMV reactivation Chi squared
    Comparison groups
    Verum3 v Control3
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.349
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 CMV reactivation log-rank test
    Comparison groups
    Verum3 v Control3
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 Logrank
    Confidence interval

    Secondary: Occurrence of at least one EBV reactivation

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    End point title
    		 Occurrence of at least one EBV reactivation
    End point description
    End point type
    Secondary
    End point timeframe
    at all visits during the Treatment and follow-up period
    End point values
    		 Verum3 Control3
    Number of subjects analysed
    9
    14
    Units: event
    7
    6
    Statistical analysis title
    		 EBV reactivation
    Comparison groups
    Verum3 v Control3
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.099
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Occurrence of CMV viral load requiring treatment, cumulative dose valganciclovir

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    End point title
    		 Occurrence of CMV viral load requiring treatment, cumulative dose valganciclovir
    End point description
    End point type
    Secondary
    End point timeframe
    at all visits during the Treatment and follow-up period
    End point values
    		 Verum3 Control3
    Number of subjects analysed
    4
    6 [4]
    Units: mg
        arithmetic mean (standard deviation)
    26550 ( 20238 )
    32721 ( 18680 )
    Notes
    [4] - Control Group: 14 subjects; cmv reactivation: 9 subjects; Treatment with valganciclovir: 6 subjects
    Statistical analysis title
    		 T-test
    Comparison groups
    Verum3 v Control3
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.621
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Occurrence of EBV viral load requiring treatment

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    End point title
    		 Occurrence of EBV viral load requiring treatment
    End point description
    End point type
    Secondary
    End point timeframe
    at all visits during the Treatment and follow-up period
    End point values
    		 Verum3 Control3
    Number of subjects analysed
    7 [5]
    6 [6]
    Units: subjects
    3
    3
    Notes
    [5] - Verum Group: 9 subjects, EBV reactivation: 7 subjects, Treatment with Rituximab: 3 subjects
    [6] - Control Group: 14 subjects, EBV reactivation: 6 subjects, Treatment with Rituximab: 3 subjects
    Statistical analysis title
    		 Chi squared
    Comparison groups
    Verum3 v Control3
    Number of subjects included in analysis
    13
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.343
    Method
    		 Chi-squared
    Confidence interval

    Secondary: De novo onset of acute GvHD

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    End point title
    		 De novo onset of acute GvHD
    End point description
    End point type
    Secondary
    End point timeframe
    at all visits during Treatment and follow up period
    End point values
    		 Verum3 Control3
    Number of subjects analysed
    9
    14
    Units: event
    3
    7
    Attachments
    		 Untitled (Filename: Logrank_cumulative_incidence_acute_GvHD.pdf)
    Statistical analysis title
    		 Logrank
    Comparison groups
    Verum3 v Control3
    Number of subjects included in analysis
    23
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.55
    Method
    		 Logrank
    Confidence interval

    Secondary: Occurrence of CMV viral load requiring treatment, days of valganciclovir treatment

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    End point title
    		 Occurrence of CMV viral load requiring treatment, days of valganciclovir treatment
    End point description
    End point type
    Secondary
    End point timeframe
    at all visits during the Treatment and follow-up period
    End point values
    		 Verum3 Control3
    Number of subjects analysed
    4
    6
    Units: days
        arithmetic mean (standard deviation)
    22.00 ( 17.5 )
    37.14 ( 28.4 )
    Statistical analysis title
    		 t-test
    Comparison groups
    Verum3 v Control3
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.365
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from day 1 (day of first IMP Administration, for Control Group day 1 = day 28 after SCT) until day 204 after SCT
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Verum (IMP administered)
    Reporting group description
    		 patients who switched from Verum to Control Group without any IMP administered were assigned to the reporting group "Control (no IMP administered)"

    Reporting group title
    Control (no IMP administered)
    Reporting group description
    		 Patients who were randomized to the Verum Group but switched to the Control Group without any IMP Administration were assigned to the reporting Group "Control (no IMP administered)"

    Serious adverse events
    		 Verum (IMP administered) Control (no IMP administered)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 9 (77.78%)
    10 / 16 (62.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Joint arthroplasty
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Radiculopathy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute graft versus host disease in liver
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticular perforation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 16 (18.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Verum (IMP administered) Control (no IMP administered)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    16 / 16 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Chloroma
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Plasma cell myeloma
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    Haematoma
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    hypertension
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Circulatory collapse
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Lymphoedema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    4 / 9 (44.44%)
    1 / 16 (6.25%)
         occurrences all number
    8
    1
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    6 / 16 (37.50%)
         occurrences all number
    0
    7
    Oedema peripheral
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 16 (6.25%)
         occurrences all number
    5
    2
    Chills
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Mucosal inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    4
    4
    Acute graft versus host disease in skin
         subjects affected / exposed
    1 / 9 (11.11%)
    5 / 16 (31.25%)
         occurrences all number
    2
    6
    Acute graft versus host disease in intestine
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Chronic graft versus host disease
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 16 (18.75%)
         occurrences all number
    3
    4
    Chronic graft versus host disease in skin
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Chronic graft versus host disease in intestine
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Graft versus host disease in liver
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Graft versus host disease
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Secondary immunodeficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Oral mucosal blistering
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Sleep disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Confusional state
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    10
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 16 (6.25%)
         occurrences all number
    3
    1
    Alpha hydroxybutyrate dehydrogenase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Amylase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    10
    Blood pressure increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Clostridium test positive
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Electrolyte depletion
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Electrophoresis abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Serum ferritin increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Blood folate decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 16 (18.75%)
         occurrences all number
    11
    10
    Protein total decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    Blood immunoglobulin G decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Immunoglobulins decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    International normalised ratio increased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Blood potassium increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    4
    5
    Body temperature increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Blood creatine increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    5
    0
    Blood creatinine increased
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 16 (18.75%)
         occurrences all number
    12
    12
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    8
    Lipase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 16 (0.00%)
         occurrences all number
    12
    0
    Carbon monoxide diffusing capacity decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Blood magnesium decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Monoclonal immunoglobulin present
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    Sensory level abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Staphylococcus test positive
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    16
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Pericardial effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nervous system disorders
    Burning sensation feet
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 16 (0.00%)
         occurrences all number
    6
    0
    Dysgeusia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Paresis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Polyneuropathy
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Syncope
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 9 (22.22%)
    7 / 16 (43.75%)
         occurrences all number
    18
    19
    Granulocytopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Immune thrombocytopenic purpura
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    10
    Splenic infarction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    1 / 9 (11.11%)
    4 / 16 (25.00%)
         occurrences all number
    1
    6
    Lymphadenopathy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Monocytosis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 16 (18.75%)
         occurrences all number
    2
    11
    Ear and labyrinth disorders
    Middle ear effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Eye disorders
    Erythema of eyelid
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Chronic gastritis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 16 (6.25%)
         occurrences all number
    13
    3
    Diverticular perforation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 9 (22.22%)
    4 / 16 (25.00%)
         occurrences all number
    4
    4
    Mucosal inflammation oral
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Gastric disorder
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Gastric mucosa erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Dry mouth
         subjects affected / exposed
    1 / 9 (11.11%)
    4 / 16 (25.00%)
         occurrences all number
    1
    4
    Constipation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Pancreatitis acute
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Proctalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Oral mucosal erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    4 / 9 (44.44%)
    5 / 16 (31.25%)
         occurrences all number
    6
    9
    Tongue coated
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 16 (18.75%)
         occurrences all number
    3
    3
    Erythema
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Skin atrophy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin fissures
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Sensitive skin
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Papule
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Penile ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    stasis dermatitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    2
    2
    Renal failure
         subjects affected / exposed
    2 / 9 (22.22%)
    6 / 16 (37.50%)
         occurrences all number
    3
    9
    Pollakiuria
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Protein urine present
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypothyroidism
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Muscular weakness
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    3
    Bacteriuria
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Bronchitis viral
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Epstein-Barr virus infection
         subjects affected / exposed
    4 / 9 (44.44%)
    6 / 16 (37.50%)
         occurrences all number
    7
    11
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 9 (44.44%)
    6 / 16 (37.50%)
         occurrences all number
    8
    8
    Hepatitis infectious mononucleosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Enteritis infectious
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Catheter site infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 9 (11.11%)
    5 / 16 (31.25%)
         occurrences all number
    1
    6
    Parvovirus B19 infection
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Sepsis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    Systemic mycosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cytomegalovirus infection
         subjects affected / exposed
    3 / 9 (33.33%)
    10 / 16 (62.50%)
         occurrences all number
    3
    20
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    1
    3
    Dehydration
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Folate deficiency
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Haemosiderosis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    5
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Vitamin B12 deficiency
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    6
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2016
    Clarification of preexisting safety endpoints, changes in forbidden/permitted concomitant medication, additional blood samples for immunomonitoring and Determination of viral load

    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.
    Small number of subjects recruited Limits informative value of results
    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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