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    Clinical Trial Results:
    Randomized, Multi-centre, Phase II Trial to compare the Event-Free Survival of Clofarabine / Ara-C (ClAraC) or of FLAMSA Treatment in Patients with High Risk AML or Advanced MDS scheduled for Allogeneic Stem Cell Transplantation

    Summary
    EudraCT number
    		 2010-021944-17
    Trial protocol
    		 DE  
    Global end of trial date
    15 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Dec 2023
    First version publication date
    14 Dec 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ClAraC-SCT-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01423175
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hannover Medical School
    Sponsor organisation address
    Carl-Neuberg-Str. 1, Hannover, Germany, 30625
    Public contact
    Stabsstelle Zentrum für Klinische Studien, Hannover Medical School, EudraCT@mh-hannover.de
    Scientific contact
    Stabsstelle Zentrum für Klinische Studien, Hannover Medical School, EudraCT@mh-hannover.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
    14 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that event-free survival is improved by using ClAraC instead of the FLAMSA regimen.
    Protection of trial subjects
    The clinical trial was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and with the standards of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). A continuous risk assessment was performed during the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2011
    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: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    53
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with high risk acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) scheduled for allogeneic stem cell transplantation (SCT) were included in this clinical trial.

    Pre-assignment
    Screening details
    		 Eligibility will be determined based upon the inclusion and exclusion criteria

    Period 1
    Period 1 title
    overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    open-label

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ClAraC gruop
    Arm description
    		 Clofarabine 30 mg/m² i.v., one hour infusion d – 16 to – 12 Ara-C 1000 mg/m² i.v. (two hour infusion three hours after clofarabine) d – 16 to – 12
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clofarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    Clofarabine 30 mg/m² i.v., one hour infusion

    Investigational medicinal product name
    Ara-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    1000 mg/m² i.v. (two hour infusion three hours after clofarabine)

    Arm title
    		 FLAMSA group
    Arm description
    		 Fludarabine 30 mg/m² i.v., one hour infusion d – 13 to d - 10 Amsacrine 100 mg/m² i.v., one hour infusion d – 13 to d - 10 Ara-C 2000 mg/m² i.v., (two hour infusion three hours after fludarabine) d – 13 to d - 10
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    30 mg/m² i.v., one hour infusion

    Investigational medicinal product name
    Amsacrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    Amsacrine 100 mg/m² i.v., one hour infusion

    Investigational medicinal product name
    Ara-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    2000 mg/m² i.v., (two hour infusion three hours after fludarabine)

    Number of subjects in period 1
    		ClAraC gruop FLAMSA group
    Started
    30
    30
    Completed
    30
    30

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    ClAraC gruop
    Reporting group description
    		 Clofarabine 30 mg/m² i.v., one hour infusion d – 16 to – 12 Ara-C 1000 mg/m² i.v. (two hour infusion three hours after clofarabine) d – 16 to – 12

    Reporting group title
    FLAMSA group
    Reporting group description
    		 Fludarabine 30 mg/m² i.v., one hour infusion d – 13 to d - 10 Amsacrine 100 mg/m² i.v., one hour infusion d – 13 to d - 10 Ara-C 2000 mg/m² i.v., (two hour infusion three hours after fludarabine) d – 13 to d - 10

    Primary: Event-free survival

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    End point title
    		 Event-free survival
    End point description
    To demonstrate that event-free survival is improved by using ClAraC instead of the FLAMSA regimen.
    End point type
    Primary
    End point timeframe
    days
    End point values
    		 ClAraC gruop FLAMSA group
    Number of subjects analysed
    30
    30
    Units: days
        arithmetic mean (standard error)
    656.6 ± 84.6
    565.6 ± 49.2
    Statistical analysis title
    		 event-free survival
    Comparison groups
    ClAraC gruop v FLAMSA group
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.1774
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 3.13

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival is defined as time from randomisation until date of death due to any cause. Living patients were censored at the end of the trial.
    End point type
    Secondary
    End point timeframe
    End of trial
    End point values
    		 ClAraC gruop FLAMSA group
    Number of subjects analysed
    30
    30
    Units: percentage death
        number (not applicable)
    53.3
    40.0
    No statistical analyses for this end point

    Secondary: Relapse-free survival

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    End point title
    		 Relapse-free survival
    End point description
    Relapse-free survival is defined as time from randomization until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurs first. Patients were censored at the end of the trial if no event had been observed. The p-value of the stratified Logrank-test is 0.2518.
    End point type
    Secondary
    End point timeframe
    End of trial
    End point values
    		 ClAraC gruop FLAMSA group
    Number of subjects analysed
    30
    30
    Units: No. events/ no. patients
        number (not applicable)
    17
    13
    Statistical analysis title
    		 stratified Cox regression
    Statistical analysis description
    A stratified Cox regression model was used to compare the two treatment arms. The model shows a Hazard Ratio > 1 for the experimental treatment. adjusted for center and remission state, all patients
    Comparison groups
    ClAraC gruop v FLAMSA group
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3101
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.706
         upper limit
    		 3.084
    Variability estimate
    Standard deviation
    Dispersion value
    0.3101

    Secondary: Cardiac toxicity

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    End point title
    		 Cardiac toxicity
    End point description
    A logistic regression analysis was performed to compare the two treatment arms. The stratified analysis included only remission state and not center due to convergence problems for maximum likelihood estimates of variable center.
    End point type
    Secondary
    End point timeframe
    Cardiac toxicity was observed from the first administration of IMP until day 30 after SCT.
    End point values
    		 ClAraC gruop FLAMSA group
    Number of subjects analysed
    30
    30
    Units: no. events/ no. events
        number (not applicable)
    26
    27
    Statistical analysis title
    		 Regressions Analysis
    Statistical analysis description
    A logistic regression analysis was performed to compare the two treatment arms. The stratified analysis included only remission state and not center due to convergence problems for maximum likelihood estimates of variable center
    Comparison groups
    ClAraC gruop v FLAMSA group
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7304
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.146
         upper limit
    		 3.846
    Variability estimate
    Standard deviation
    Dispersion value
    0.75

    Secondary: Rate of engraftment

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    End point title
    		 Rate of engraftment
    End point description
    Engraftment was defined in the study protocol by leukocytes > 1.000/μl or neutrophils >500/μl during the course of the study. However, in order to comply with more recent EBMT guidelines, the definition of only neutrophils > 500/μl seems to be more suitable. Both definitions lead to the same results
    End point type
    Secondary
    End point timeframe
    during study
    End point values
    		 ClAraC gruop FLAMSA group
    Number of subjects analysed
    30
    30
    Units: No. Events /No. Patients
        number (not applicable)
    28
    28
    Statistical analysis title
    		 Regression analysis
    Comparison groups
    FLAMSA group v ClAraC gruop
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9704
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.134
         upper limit
    		 8.056
    Variability estimate
    Standard deviation
    Dispersion value
    1.04

    Secondary: Kinetics of chimerism after SCT

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    End point title
    		 Kinetics of chimerism after SCT
    End point description
    Analysis of chimerism refers to the measurement of donor cells after SCT. If the transplantation is successful, it is anticipated that the percentage of donor cells will ideally be at 100%. The more the measurement deviates from 100% (i.e. decreases), the more likely is a relapse of the disease
    End point type
    Secondary
    End point timeframe
    Results are presented for the 18 months time-point (the minimum observation time of the trial) because it is of interest whether the patients develop an early relapse and are able to keep the transplant over time.
    End point values
    		 ClAraC gruop FLAMSA group
    Number of subjects analysed
    30
    30
    Units: No. Events /No. Patients
        number (not applicable)
    11
    10
    Statistical analysis title
    		 Regression analysis
    Comparison groups
    ClAraC gruop v FLAMSA group
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7698
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.404
         upper limit
    		 3.404
    Variability estimate
    Standard deviation
    Dispersion value
    1.173

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the first administration of one of the IMPs until day 30 after stem cell transplantation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    FLAMSA
    Reporting group description
    		 -

    Reporting group title
    ClAraC
    Reporting group description
    		 -

    Serious adverse events
    		 FLAMSA ClAraC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 30 (23.33%)
    7 / 30 (23.33%)
         number of deaths (all causes)
    3
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Vascular disorders
    Capillary leak syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Venoocclusive disease
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Disease progression
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Blood lactic acid increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Transplant failure
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cardiac arrest
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Coma
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophagitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal failure
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Intestinal sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral haemorrhagic cystitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 FLAMSA ClAraC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    30 / 30 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vascular disorders
    Capillary leak syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Arterial haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Circulatory collapse
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Extremity necrosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Pallor
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    7 / 30 (23.33%)
    12 / 30 (40.00%)
         occurrences all number
    10
    20
    Hypertensive crisis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    16 / 30 (53.33%)
    19 / 30 (63.33%)
         occurrences all number
    28
    30
    Hot flush
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    Haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    5 / 30 (16.67%)
         occurrences all number
    1
    5
    Haematoma
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 30 (6.67%)
         occurrences all number
    4
    2
    Flushing
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 30 (13.33%)
         occurrences all number
    4
    4
    Peripheral coldness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Venoocclusive disease
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    5 / 30 (16.67%)
    3 / 30 (10.00%)
         occurrences all number
    6
    3
    Catheter site haematoma
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Catheter site haemorrhage
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    5
    4
    Catheter site inflammation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Administration site papule
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Axillary pain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Catheter site pain
         subjects affected / exposed
    6 / 30 (20.00%)
    5 / 30 (16.67%)
         occurrences all number
    8
    9
    Catheter site related reaction
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Catheter site swelling
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 30 (3.33%)
         occurrences all number
    4
    1
    Chest discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Chest pain
         subjects affected / exposed
    5 / 30 (16.67%)
    7 / 30 (23.33%)
         occurrences all number
    10
    7
    Chills
         subjects affected / exposed
    18 / 30 (60.00%)
    12 / 30 (40.00%)
         occurrences all number
    22
    16
    Early satiety
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Face oedema
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Facial pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Injection site reaction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    3
    Mucosal dryness
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Injection site extravasation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Gait disturbance
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Feeling hot
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Fatigue
         subjects affected / exposed
    18 / 30 (60.00%)
    24 / 30 (80.00%)
         occurrences all number
    25
    34
    Mucosal haemorrhage
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Mucosal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    13 / 30 (43.33%)
    12 / 30 (40.00%)
         occurrences all number
    16
    18
    Mucosal ulceration
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Oedema
         subjects affected / exposed
    11 / 30 (36.67%)
    15 / 30 (50.00%)
         occurrences all number
    19
    20
    Oedema peripheral
         subjects affected / exposed
    13 / 30 (43.33%)
    14 / 30 (46.67%)
         occurrences all number
    21
    31
    Pain
         subjects affected / exposed
    2 / 30 (6.67%)
    8 / 30 (26.67%)
         occurrences all number
    2
    9
    Polyp
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    27 / 30 (90.00%)
    28 / 30 (93.33%)
         occurrences all number
    68
    81
    Sensation of foreign body
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 30 (13.33%)
         occurrences all number
    3
    5
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    Engraftment syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Genital rash
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Genital blister
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Breast pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Genital swelling
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Menstrual discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Menstrual disorder
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Pelvic pain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vulvovaginal burning sensation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Bronchial haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    5 / 30 (16.67%)
    9 / 30 (30.00%)
         occurrences all number
    6
    15
    Dysphonia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Dyspnoea
         subjects affected / exposed
    6 / 30 (20.00%)
    7 / 30 (23.33%)
         occurrences all number
    9
    8
    Nasal discomfort
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    11 / 30 (36.67%)
    6 / 30 (20.00%)
         occurrences all number
    15
    11
    Haemoptysis
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    Hiccups
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 30 (13.33%)
         occurrences all number
    2
    5
    Hypoxia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    2
    3
    Laryngeal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    3
    3
    Nasal dryness
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    5 / 30 (16.67%)
    3 / 30 (10.00%)
         occurrences all number
    5
    3
    Orthopnoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Pharyngeal erythema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    2
    4
    Sneezing
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pulmonary congestion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pulmonary oedema
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Respiratory failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Productive cough
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Tachypnoea
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Agitation
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Anorexia and bulimia syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Anxiety
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    4
    Delirium
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Psychiatric symptom
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    Hallucination
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    3
    Hallucination, visual
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    11 / 30 (36.67%)
    12 / 30 (40.00%)
         occurrences all number
    14
    15
    Mental disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Sleep disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    Restlessness
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Sopor
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Tension
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Blood pressure diastolic decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood pressure abnormal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Blood glucose increased
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    3
    8
    Blood creatinine increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    5
    Blood pH decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Immunoglobulins decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Heart rate irregular
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    General physical condition abnormal
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Enterococcus test positive
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Coagulation factor decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Coagulation factor XIII level decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Cardiac imaging procedure abnormal
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Inflammatory marker increased
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    C-reactive protein increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    International normalised ratio increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pancreatic enzymes decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    6 / 30 (20.00%)
    3 / 30 (10.00%)
         occurrences all number
    24
    10
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    0
    4
    Lymphocyte count decreased
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 30 (3.33%)
         occurrences all number
    17
    2
    Polyomavirus test positive
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pulmonary function test abnormal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Roseolovirus test positive
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 30 (3.33%)
    8 / 30 (26.67%)
         occurrences all number
    1
    9
    Urine lactic acid increased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Viral titre increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vital capacity decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Weight increased
         subjects affected / exposed
    19 / 30 (63.33%)
    23 / 30 (76.67%)
         occurrences all number
    28
    39
    White blood cell count decreased
         subjects affected / exposed
    6 / 30 (20.00%)
    7 / 30 (23.33%)
         occurrences all number
    36
    24
    Platelet count decreased
         subjects affected / exposed
    6 / 30 (20.00%)
    7 / 30 (23.33%)
         occurrences all number
    65
    91
    pH urine decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Joint injury
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Anal injury
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Procedural dizziness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Scratch
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Spinal fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Sternal fracture
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Subdural haematoma
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vascular access site pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    2
    Bradycardia
         subjects affected / exposed
    7 / 30 (23.33%)
    7 / 30 (23.33%)
         occurrences all number
    8
    10
    Cardiac failure
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Cardiomegaly
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Cyanosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Extrasystoles
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pericardial effusion
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Cardiovascular disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    4
    5
    Tachyarrhythmia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    17 / 30 (56.67%)
    14 / 30 (46.67%)
         occurrences all number
    27
    26
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Burning sensation
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Depressed level of consciousness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    13 / 30 (43.33%)
    11 / 30 (36.67%)
         occurrences all number
    15
    14
    Dysarthria
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    13 / 30 (43.33%)
    17 / 30 (56.67%)
         occurrences all number
    23
    33
    Polyneuropathy
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    4
    Hypertonia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hypotonia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    5
    0
    Orthostatic intolerance
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    6 / 30 (20.00%)
    3 / 30 (10.00%)
         occurrences all number
    6
    3
    Hyperaesthesia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Seizure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Syncope
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Tremor
         subjects affected / exposed
    5 / 30 (16.67%)
    3 / 30 (10.00%)
         occurrences all number
    5
    4
    VIth nerve disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 30 (20.00%)
    6 / 30 (20.00%)
         occurrences all number
    73
    51
    Febrile neutropenia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hilar lymphadenopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Splenomegaly
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Coagulopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    4 / 30 (13.33%)
    6 / 30 (20.00%)
         occurrences all number
    5
    8
    Deafness neurosensory
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Hypoacusis
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Middle ear effusion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Conjunctival oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    3
    3
    Eye haemorrhage
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 30 (6.67%)
         occurrences all number
    4
    2
    Eye irritation
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Eyelid oedema
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Ocular discomfort
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Photopsia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    4 / 30 (13.33%)
    4 / 30 (13.33%)
         occurrences all number
    6
    4
    Abdominal distension
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Abdominal pain
         subjects affected / exposed
    10 / 30 (33.33%)
    12 / 30 (40.00%)
         occurrences all number
    15
    18
    Abdominal pain upper
         subjects affected / exposed
    12 / 30 (40.00%)
    8 / 30 (26.67%)
         occurrences all number
    22
    10
    Constipation
         subjects affected / exposed
    13 / 30 (43.33%)
    16 / 30 (53.33%)
         occurrences all number
    22
    25
    Anorectal disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Aphthous ulcer
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Ascites
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Coating in mouth
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Anal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    22 / 30 (73.33%)
    22 / 30 (73.33%)
         occurrences all number
    36
    42
    Dry mouth
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Dyspepsia
         subjects affected / exposed
    6 / 30 (20.00%)
    1 / 30 (3.33%)
         occurrences all number
    8
    1
    Dysphagia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Enteritis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    2
    3
    Gastric disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Gastritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    2
    3
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 30 (13.33%)
         occurrences all number
    2
    4
    Impaired gastric emptying
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Lip blister
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Lip pruritus
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    27 / 30 (90.00%)
    29 / 30 (96.67%)
         occurrences all number
    68
    69
    Melaena
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Mouth haemorrhage
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 30 (6.67%)
         occurrences all number
    8
    2
    Mouth swelling
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    Mouth ulceration
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Lip swelling
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Oesophageal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Odynophagia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Oral discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    3
    Oral pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Oral mucosal erythema
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Oral mucosal blistering
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Pancreatitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Proctalgia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    8 / 30 (26.67%)
    10 / 30 (33.33%)
         occurrences all number
    12
    19
    Tongue ulceration
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    25 / 30 (83.33%)
    22 / 30 (73.33%)
         occurrences all number
    65
    53
    Toothache
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Tongue coated
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    2
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    Hepatotoxicity
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Ocular icterus
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Pain of skin
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    Nail disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    2
    3
    Erythema
         subjects affected / exposed
    4 / 30 (13.33%)
    8 / 30 (26.67%)
         occurrences all number
    5
    9
    Dry skin
         subjects affected / exposed
    1 / 30 (3.33%)
    9 / 30 (30.00%)
         occurrences all number
    2
    12
    Dermatitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Cold sweat
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Blood blister
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Petechiae
         subjects affected / exposed
    4 / 30 (13.33%)
    9 / 30 (30.00%)
         occurrences all number
    4
    13
    Pruritus
         subjects affected / exposed
    6 / 30 (20.00%)
    10 / 30 (33.33%)
         occurrences all number
    10
    21
    Purpura
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    19 / 30 (63.33%)
    14 / 30 (46.67%)
         occurrences all number
    35
    25
    Rash maculo-papular
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Skin exfoliation
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Skin fissures
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    8 / 30 (26.67%)
    9 / 30 (30.00%)
         occurrences all number
    8
    10
    Palmar erythema
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Skin maceration
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Swelling face
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Acute kidney injury
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Dysuria
         subjects affected / exposed
    5 / 30 (16.67%)
    5 / 30 (16.67%)
         occurrences all number
    7
    5
    Chromaturia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    Haematuria
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 30 (13.33%)
         occurrences all number
    5
    4
    Urinary retention
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Renal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Renal impairment
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Renal failure
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Polyuria
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Pollakiuria
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    0
    5
    Oliguria
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Nocturia
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    3
    3
    Urinary tract pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Adrenal disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Coccydynia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Limb discomfort
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Jaw cyst
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Arthralgia
         subjects affected / exposed
    4 / 30 (13.33%)
    4 / 30 (13.33%)
         occurrences all number
    4
    5
    Back pain
         subjects affected / exposed
    8 / 30 (26.67%)
    10 / 30 (33.33%)
         occurrences all number
    9
    16
    Bone pain
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 30 (16.67%)
         occurrences all number
    3
    8
    Muscle tightness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Sjogren's syndrome
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    4 / 30 (13.33%)
    7 / 30 (23.33%)
         occurrences all number
    6
    9
    Spinal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Myosclerosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    4 / 30 (13.33%)
    4 / 30 (13.33%)
         occurrences all number
    4
    4
    Musculoskeletal disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    4 / 30 (13.33%)
    3 / 30 (10.00%)
         occurrences all number
    4
    3
    Tendon disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Candida infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Bacterial sepsis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Bacterial infection
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Catheter site abscess
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    2
    3
    Cellulitis orbital
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Catheter site infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Corynebacterium bacteraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Cystitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Cytomegalovirus gastroenteritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Herpes virus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Enterococcal infection
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
         occurrences all number
    2
    4
    Escherichia sepsis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Genital infection fungal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Pneumonia fungal
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Pseudomonas infection
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Rash pustular
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    3
    Rhinitis
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    3
    2
    Sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    3
    Intestinal sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Listeriosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Micrococcal sepsis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Stenotrophomonas infection
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Staphylococcal infection
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    3
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Sphingomonas paucimobilis infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Viral infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    4 / 30 (13.33%)
    3 / 30 (10.00%)
         occurrences all number
    4
    3
    Fluid overload
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Decreased appetite
         subjects affected / exposed
    14 / 30 (46.67%)
    12 / 30 (40.00%)
         occurrences all number
    15
    17
    Hyperkalaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Hypernatraemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Hypokalaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Hypoglycaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Malnutrition
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Polydipsia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vitamin K deficiency
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1

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

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