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    Clinical Trial Results:
    A multicenter, randomized, open-labeled study to steer immunsuppressive and antiviral therapy by measurement of virus- (CMV, ADV, HSV) specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients. An explorative study.

    Summary
    EudraCT number
    		 2009-012436-32
    Trial protocol
    		 DE  
    Global end of trial date
    26 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2023
    First version publication date
    11 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IVIST01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    24 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Prolongation of kidney function and reduced viral infections after solid organ transplantation by monitoring of virus-specific T cells followed by therapeutic intervention. The primary endpoint is eGFR (Cystatin C, Filler) 2 years after transplantation
    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
    12 Apr 2010
    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: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    64
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All children after kidney transplantation will be asked for participation within the first 4 weeks after transplantation.

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

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 non intervention group
    Arm description
    		 In the control group and the intervention group the immunosuppressive medication will be steered in the ‘normal’ target range of trough levels due to the standard protocol. In case of the control group the physician decides the application rate of the immunosuppressive medication in the normal target range of trough levels arbitrarily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sandimmune® Optoral
    Investigational medicinal product code
    Other name
    Ciclosporine A
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Ciclosporine A (CsA)-start dose is 400 mg/m²/d in two doses (maximal dose 250mg/dose), dose will be adopted to target C0-levels of 200-250 ng/ml for the first 4 weeks after transplantation, then CsA will be reduced by 50% to a target C0-level of 50-100 ng/ml (HPLC) (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) when administered together with Everolimus. Target doses are reduced to 30-75 ng/ml (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) six months after transplantation. Sandimmun® Optoral will be given on a twice-daily schedule at approximately 12-hours intervals in the morning and in the evening for the complete study duration of 23 months.

    Investigational medicinal product name
    Certican
    Investigational medicinal product code
    Other name
    Everolimus
    Pharmaceutical forms
    Tablet, Tablet and powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will be treated with Everolimus, starting four weeks after transplantation with 0.8 mg/m² Everolimus b.i.d. (maximal dose 1.5 mg/dose). Target trough levels are 3-6 ng/ml (HPLC) in the first five months and 2-5 ng/ml thereafter. Dosing should be adjusted in all patients if the Everolimus whole blood trough level is below 3 ng/ml or above 6 ng/ml (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) and below 2 ng/ml or above 5 ng/ml (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) six months after transplantation. Blood for Everolimus trough levels will be obtained from all patients. Blood should be drawn 15 minutes before the administration of the morning dose of Everolimus. For the C0 samples the date of sampling should be recorded on the Immunosuppressive Therapies CRF.

    Investigational medicinal product name
    Valcyte
    Investigational medicinal product code
    Other name
    Valganciclovir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In case of CMV-infection/-reactivation with relevant CMV-DNA-detection, in both groups an antiviral therapy with Valganciclovir will be performed. In the non-intervention group Valganciclovir will be given for 3 months The dosing of Valganciclovir will be calculated according to the following: Dose (mg) = GFR x 7 x BSA (body surface area), applied in one single dose per day; maximum dose 1 x 900 mg. If the calculated GFR exceeds 150ml/min/1,73m2, dose is calculated with a GFR of 150ml/min/1,73m2.

    Arm title
    		 intervention-group
    Arm description
    		 In the intervention group immunosuppressive therapy should be adopted due to the levels of virus-specific T cells as a direct measure of the intensity of immunosuppression in addition to classical trough level monitoring. Antiviral management should be based on the individual virus-specific immune defense assessed by the amount of virus-specific T cells.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sandimmune® Optoral
    Investigational medicinal product code
    Other name
    Ciclosporine A
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Ciclosporine A (CsA)-start dose is 400 mg/m²/d in two doses (maximal dose 250mg/dose), dose will be adopted to target C0-levels of 200-250 ng/ml for the first 4 weeks after transplantation, then CsA will be reduced by 50% to a target C0-level of 50-100 ng/ml (HPLC) (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) when administered together with Everolimus. Target doses are reduced to 30-75 ng/ml (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) six months after transplantation. Sandimmun® Optoral will be given on a twice-daily schedule at approximately 12-hours intervals in the morning and in the evening for the complete study duration of 23 months.

    Investigational medicinal product name
    Certican
    Investigational medicinal product code
    Other name
    Everolimus
    Pharmaceutical forms
    Tablet, Tablet and powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will be treated with Everolimus, starting four weeks after transplantation with 0.8 mg/m² Everolimus b.i.d. (maximal dose 1.5 mg/dose). Target trough levels are 3-6 ng/ml (HPLC) in the first five months and 2-5 ng/ml thereafter. Dosing should be adjusted in all patients if the Everolimus whole blood trough level is below 3 ng/ml or above 6 ng/ml (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) and below 2 ng/ml or above 5 ng/ml (a tolerance of ± 10% in the target C0-level is allowed for a period of 8 weeks) six months after transplantation. Blood for Everolimus trough levels will be obtained from all patients. Blood should be drawn 15 minutes before the administration of the morning dose of Everolimus. For the C0 samples the date of sampling should be recorded on the Immunosuppressive Therapies CRF.

    Investigational medicinal product name
    Valcyte
    Investigational medicinal product code
    Other name
    Valganciclovir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In case of CMV-infection/-reactivation with relevant CMV-DNA-detection, in both groups an antiviral therapy with Valganciclovir will be performed. In the intervention group, Valganciclovir therapy will only be carried out until there is a sufficient and stable number of CMV-specific CD4 T cells without DNA-detection. The dosing of Valganciclovir will be calculated according to the following: Dose (mg) = GFR x 7 x BSA (body surface area), applied in one single dose per day; maximum dose 1 x 900 mg. If the calculated GFR exceeds 150ml/min/1,73m2, dose is calculated with a GFR of 150ml/min/1,73m2.

    Number of subjects in period 1
    		non intervention group intervention-group
    Started
    33
    31
    Completed
    30
    25
    Not completed
    3
    6
         patient died by drowning in a bath tub
    1
    -
         disease relapse
    1
    1
         rejection
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    non intervention group
    Reporting group description
    		 In the control group and the intervention group the immunosuppressive medication will be steered in the ‘normal’ target range of trough levels due to the standard protocol. In case of the control group the physician decides the application rate of the immunosuppressive medication in the normal target range of trough levels arbitrarily

    Reporting group title
    intervention-group
    Reporting group description
    		 In the intervention group immunosuppressive therapy should be adopted due to the levels of virus-specific T cells as a direct measure of the intensity of immunosuppression in addition to classical trough level monitoring. Antiviral management should be based on the individual virus-specific immune defense assessed by the amount of virus-specific T cells.

    Reporting group values
    		 non intervention group intervention-group Total
    Number of subjects
    		 33 31 64
    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
        median (full range (min-max))
    		 11.33 (1.75 to 16.42) 11.92 (1.58 to 16.17) -
    Gender categorical
    Units: Subjects
        Female
    		 14 13 27
        Male
    		 19 18 37

    End points

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    End points reporting groups
    Reporting group title
    non intervention group
    Reporting group description
    		 In the control group and the intervention group the immunosuppressive medication will be steered in the ‘normal’ target range of trough levels due to the standard protocol. In case of the control group the physician decides the application rate of the immunosuppressive medication in the normal target range of trough levels arbitrarily

    Reporting group title
    intervention-group
    Reporting group description
    		 In the intervention group immunosuppressive therapy should be adopted due to the levels of virus-specific T cells as a direct measure of the intensity of immunosuppression in addition to classical trough level monitoring. Antiviral management should be based on the individual virus-specific immune defense assessed by the amount of virus-specific T cells.

    Primary: eGFR (Cystatin C, Filler) 2 years after transplantation

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    End point title
    		 eGFR (Cystatin C, Filler) 2 years after transplantation
    End point description
    End point type
    Primary
    End point timeframe
    2 years after transplantation
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    33
    31
    Units: eGFR filler
    number (confidence interval 95%)
        population A
    61.49 (44.84 to 78.14)
    62.27 (45.78 to 79.66)
        population B
    60.78 (45.99 to 75.56)
    66.19 (45.99 to 75.56)
        population C
    59.35 (44.52 to 74.18)
    61.91 (44.52 to 74.18)
    Statistical analysis title
    		 eGFR filler 2 years after transplantation
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7743
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.15
         upper limit
    		 13.55
    Variability estimate
    Standard deviation
    Dispersion value
    22.51

    Secondary: Death and relapse

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    End point title
    		 Death and relapse
    End point description
    End point type
    Secondary
    End point timeframe
    during participation in the study , over the whole time
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    33
    31
    Units: death and relapse
    2
    2
    No statistical analyses for this end point

    Secondary: histological evidence of acute rejection and type

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    End point title
    		 histological evidence of acute rejection and type
    End point description
    Protocol defined biopsy (6 months after transplantation) was performed on 51 patients. For one patient in the non-intervention group (Center No.=1, Subject No.=11), the sample material was insufficient for histological assessment. In the protocol defined biopsies, only acute rejections were detected.
    End point type
    Secondary
    End point timeframe
    over the whole duration of the study
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    26
    24
    Units: rejections
        Borderline
    11
    8
        Banff type IA
    3
    4
        Banff type IB
    2
    0
        Banff type IIA
    1
    1
        Total
    17
    13
    Statistical analysis title
    		 chi squared test
    Comparison groups
    intervention-group v non intervention group
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4186
    Method
    		 Chi-squared
    Confidence interval

    Secondary: CMV DNA

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    End point title
    		 CMV DNA
    End point description
    Number of patients with CMV-DNA ≥ the cut-off value of 1000 copies/ml
    End point type
    Secondary
    End point timeframe
    over the duration of the study
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    33
    31
    Units: number of patients with CMV DNA
    2
    2
    Statistical analysis title
    		 Fishers exact test
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: ADV DNA

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    End point title
    		 ADV DNA
    End point description
    Number of patients with ADV-DNA ≥ the cut-off value of 1000 copies/ml
    End point type
    Secondary
    End point timeframe
    over the duration of the study
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    33
    31
    Units: number of patients with ADV DNA
    1
    1
    Statistical analysis title
    		 Fishers exact test
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: HSV DNA

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    End point title
    		 HSV DNA
    End point description
    Number of patients with HSV-DNA ≥ the cut-off value of 1000 copies/ml
    End point type
    Secondary
    End point timeframe
    over the duration of the study participation
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    33
    31
    Units: number of patients with HSV DNA
    0
    0
    No statistical analyses for this end point

    Secondary: EBV DNA

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    End point title
    		 EBV DNA
    End point description
    Number of patients with EBV-DNA ≥ the cut-off value of 1000 copies/ml
    End point type
    Secondary
    End point timeframe
    during the duration of the study participation
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    33
    31
    Units: number of patients with EBV DNA
    14
    7
    Statistical analysis title
    		 chi squared test
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.00911
    Method
    		 Chi-squared
    Confidence interval

    Secondary: dose of study medication Everolimus

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    End point title
    		 dose of study medication Everolimus
    End point description
    The analysis of the dose of the study medications is performed on 55 patients who completed the treatment regimen according to the study protocol (population B). Mean daily dose/m2 (mg/m2) from month 7 after transplantation to the end of the study is calculated for each patient and compared descriptively between the treatment groups using two-sided t-tests. For one patient (Center No.=3 & Subject No.=5) who did not participate Visit 9 (Month 7), data from Visit 10 (Month 8) until the end of the study are utilised in the analyses.
    End point type
    Secondary
    End point timeframe
    Mean daily dose/m2 (mg/m2) from month 7 after transplantation to the end of the study is calculated for each patient and compared descriptively between the treatment groups
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    30
    25
    Units: mg/m2
        number (not applicable)
    1.15
    0.82
    Statistical analysis title
    		 Mean difference
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0039
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: trough blood level of study medication Everolimus

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    End point title
    		 trough blood level of study medication Everolimus
    End point description
    The analysis of the trough blood level of the study medications is performed on 55 patients who completed the treatment regimen according to the study protocol (population B). Mean trough blood level (µg/L) from month 7 after transplantation to the end of the study is calculated for each patient and compared between the treatment groups using t tests. For one patient (Center No.=3 & Subject No.=5) who did not participate Visit 9 (Month 7), data from Visit 10 (Month 8) until the end of the study are utilised in the analyses.
    End point type
    Secondary
    End point timeframe
    from month 7 after transplantation to the end of the study is calculated for each patient
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    30
    25
    Units: microgramms/L
        number (not applicable)
    4.47
    3.46
    Statistical analysis title
    		 t test
    Comparison groups
    intervention-group v non intervention group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: dose of study medication Ciclosporin A

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    End point title
    		 dose of study medication Ciclosporin A
    End point description
    The analysis of the dose of the study medications is performed on 55 patients who completed the treatment regimen according to the study protocol (population B). Mean daily dose/m2 (mg/m2) from month 7 after transplantation to the end of the study is calculated for each patient and compared descriptively between the treatment groups using two-sided t-tests. For one patient (Center No.=3 & Subject No.=5) who did not participate Visit 9 (Month 7), data from Visit 10 (Month 8) until the end of the study are utilised in the analyses.
    End point type
    Secondary
    End point timeframe
    Mean daily dose/m2 (mg/m2) from month 7 after transplantation to the end of the study
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    30
    25
    Units: mg/m2
        number (not applicable)
    88.38
    78.43
    Statistical analysis title
    		 t test
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.1283
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: through blood level of Ciclosporin A

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    End point title
    		 through blood level of Ciclosporin A
    End point description
    The analysis of the trough blood level of the study medications is performed on 55 patients who completed the treatment regimen according to the study protocol (population B). Mean trough blood level (µg/L) from month 7 after transplantation to the end of the study is calculated for each patient and compared between the treatment groups using t tests. For one patient (Center No.=3 & Subject No.=5) who did not participate Visit 9 (Month 7), data from Visit 10 (Month 8) until the end of the study are utilised in the analyses.
    End point type
    Secondary
    End point timeframe
    Mean trough blood level (µg/L) from month 7 after transplantation to the end of the study
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    30
    25
    Units: microgramms/L
        number (not applicable)
    64.05
    47.36
    Statistical analysis title
    		 t test
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Glucocorticoids

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    End point title
    		 Glucocorticoids
    End point description
    The analysis of the therapy with glucocorticoids is performed on 55 patients who completed the treatment regimen according to the study protocol (population B). The number of patients with oral therapy with glucocorticoids 2 years after transplantation is compared between the treatment groups using a descriptive chi-squared test.
    End point type
    Secondary
    End point timeframe
    The number of patients with oral therapy with glucocorticoids 2 years after transplantation
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    30
    25
    Units: number of patients with oral GCR-A
    14
    5
    Statistical analysis title
    		 chi squared test
    Comparison groups
    non intervention group v intervention-group
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0384
    Method
    		 Chi-squared
    Confidence interval

    Secondary: clinically indicated biopsy

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    End point title
    		 clinically indicated biopsy
    End point description
    End point type
    Secondary
    End point timeframe
    over the duration of the study
    End point values
    		 non intervention group intervention-group
    Number of subjects analysed
    19
    11
    Units: indicated biopsy and rejection
        Borderline
    7
    1
        Banff type IA
    2
    3
        Banff type IB
    7
    4
        Banff type IIA
    1
    3
        Banff type IIB
    1
    0
        Banff type III
    1
    0
        Total
    19
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE occurring after study start. Medical conditions/diseases present before study start are only considered AE if they worsen after study start.
    Adverse event reporting additional description
    Numbers in the non-serious adverse events section reflect all adverse events occurring during the study (non-serious and serious).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 -

    Reporting group title
    non-intervention
    Reporting group description
    		 -

    Serious adverse events
    		 intervention non-intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 31 (80.65%)
    28 / 33 (84.85%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Face oedema
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site calcification
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    8 / 31 (25.81%)
    11 / 33 (33.33%)
         occurrences causally related to treatment / all
    8 / 10
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    8 / 31 (25.81%)
    14 / 33 (42.42%)
         occurrences causally related to treatment / all
    1 / 14
    2 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthopnoea
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         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
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    11 / 31 (35.48%)
    7 / 33 (21.21%)
         occurrences causally related to treatment / all
    13 / 21
    9 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrostomy tube site complication
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal lymphocele
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt blood flow excessive
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 33 (9.09%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 31 (12.90%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    6 / 31 (19.35%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    4 / 7
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (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
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocyturia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Micturition disorder
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal necrosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Diabetes insipidus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (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
    Abscess limb
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteriuria
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    6 / 6
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    9 / 31 (29.03%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    7 / 9
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Human bocavirus infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 33 (9.09%)
         occurrences causally related to treatment / all
    2 / 4
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 33 (9.09%)
         occurrences causally related to treatment / all
    6 / 8
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    9 / 31 (29.03%)
    5 / 33 (15.15%)
         occurrences causally related to treatment / all
    17 / 18
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    8 / 31 (25.81%)
    3 / 33 (9.09%)
         occurrences causally related to treatment / all
    4 / 11
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid intake reduced
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercreatininaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    4 / 7
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 intervention non-intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 31 (100.00%)
    33 / 33 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Sebaceous adenoma
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Skin papilloma
         subjects affected / exposed
    3 / 31 (9.68%)
    10 / 33 (30.30%)
         occurrences all number
    4
    11
    Vascular disorders
    Arteriovenous fistula
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Haematoma
         subjects affected / exposed
    5 / 31 (16.13%)
    3 / 33 (9.09%)
         occurrences all number
    5
    3
    Hypertension
         subjects affected / exposed
    0 / 31 (0.00%)
    5 / 33 (15.15%)
         occurrences all number
    0
    6
    Lymphoedema
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Shock
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Venous thrombosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Pregnancy, puerperium and perinatal conditions
    Umbilical granuloma
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    3
    0
    Drowning
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Face oedema
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Generalised oedema
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Granuloma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Impaired healing
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Medical device pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Medical device site calcification
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Medical device site erythema
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Medical device site granuloma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Medical device site inflammation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    7 / 31 (22.58%)
    8 / 33 (24.24%)
         occurrences all number
    9
    15
    Pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    18 / 31 (58.06%)
    24 / 33 (72.73%)
         occurrences all number
    69
    76
    Vaccination site pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Immune system disorders
    Immunodeficiency
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Kidney transplant rejection
         subjects affected / exposed
    8 / 31 (25.81%)
    14 / 33 (42.42%)
         occurrences all number
    14
    20
    Renal transplant failure
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Adipomastia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Breast swelling
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Genital rash
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Gynaecomastia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Menorrhagia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Scrotal erythema
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    26 / 31 (83.87%)
    19 / 33 (57.58%)
         occurrences all number
    61
    38
    Dyspnoea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 33 (12.12%)
         occurrences all number
    4
    7
    Hyperventilation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 33 (6.06%)
         occurrences all number
    2
    2
    Obstructive airways disorder
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    7 / 31 (22.58%)
    10 / 33 (30.30%)
         occurrences all number
    9
    15
    Orthopnoea
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Pharyngeal erythema
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Pleural effusion
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    2
    Respiratory failure
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 33 (6.06%)
         occurrences all number
    2
    2
    Rhinorrhoea
         subjects affected / exposed
    7 / 31 (22.58%)
    7 / 33 (21.21%)
         occurrences all number
    10
    12
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Behaviour disorder
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Encopresis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Enuresis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Blood albumin decreased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Blood bicarbonate increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    16 / 31 (51.61%)
    13 / 33 (39.39%)
         occurrences all number
    34
    24
    Enterococcus test positive
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Klebsiella test positive
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Investigation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Liver function test increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Mammogram abnormal
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Arthropod bite
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Arthropod sting
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Bone contusion
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Complications of transplant surgery
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Craniocerebral injury
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Foot fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Forearm fracture
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Gastrostomy tube site complication
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Incision site haematoma
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 33 (6.06%)
         occurrences all number
    2
    2
    Incisional hernia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Ligament rupture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Post procedural swelling
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Postoperative wound complication
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Radius fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Renal lymphocele
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Shunt aneurysm
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Shunt blood flow excessive
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Stoma site pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    2
    Suture related complication
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Ulna fracture
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Traumatic haematoma
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Vaccination complication
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    2
    Congenital, familial and genetic disorders
    Cryptorchism
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hydrocele
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Pericardial effusion
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 33 (9.09%)
         occurrences all number
    2
    3
    Headache
         subjects affected / exposed
    14 / 31 (45.16%)
    15 / 33 (45.45%)
         occurrences all number
    22
    31
    Loss of consciousness
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Petit mal epilepsy
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 31 (19.35%)
    8 / 33 (24.24%)
         occurrences all number
    7
    8
    Hypochromic anaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    8 / 31 (25.81%)
    2 / 33 (6.06%)
         occurrences all number
    8
    2
    Middle ear effusion
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    1
    3
    Tympanic membrane hyperaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    Vertigo
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    3 / 31 (9.68%)
    5 / 33 (15.15%)
         occurrences all number
    4
    6
    Eye haematoma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Papilloedema
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    8 / 31 (25.81%)
    3 / 33 (9.09%)
         occurrences all number
    10
    5
    Abdominal pain upper
         subjects affected / exposed
    11 / 31 (35.48%)
    6 / 33 (18.18%)
         occurrences all number
    11
    7
    Aphthous ulcer
         subjects affected / exposed
    7 / 31 (22.58%)
    8 / 33 (24.24%)
         occurrences all number
    9
    21
    Ascites
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Chapped lips
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    3
    Diarrhoea
         subjects affected / exposed
    17 / 31 (54.84%)
    22 / 33 (66.67%)
         occurrences all number
    33
    37
    Dyspepsia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Enteritis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Flatulence
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 33 (3.03%)
         occurrences all number
    4
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Gingival hypertrophy
         subjects affected / exposed
    17 / 31 (54.84%)
    17 / 33 (51.52%)
         occurrences all number
    20
    17
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Lip blister
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    5 / 31 (16.13%)
    3 / 33 (9.09%)
         occurrences all number
    5
    4
    Oesophagitis
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Oral disorder
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Oral mucosal blistering
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Post-tussive vomiting
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    14 / 31 (45.16%)
    21 / 33 (63.64%)
         occurrences all number
    35
    42
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 31 (19.35%)
    8 / 33 (24.24%)
         occurrences all number
    7
    10
    Alopecia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Blister
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Dandruff
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Eczema
         subjects affected / exposed
    1 / 31 (3.23%)
    5 / 33 (15.15%)
         occurrences all number
    1
    5
    Erythema
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Hirsutism
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Hyperkeratosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypertrichosis
         subjects affected / exposed
    18 / 31 (58.06%)
    18 / 33 (54.55%)
         occurrences all number
    18
    18
    Hypertrophic scar
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    3
    0
    Keloid scar
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Papule
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    6 / 31 (19.35%)
    2 / 33 (6.06%)
         occurrences all number
    6
    2
    Rash papular
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Scar pain
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 33 (6.06%)
         occurrences all number
    2
    2
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Skin exfoliation
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Skin striae
         subjects affected / exposed
    0 / 31 (0.00%)
    3 / 33 (9.09%)
         occurrences all number
    0
    3
    Swelling face
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Urticaria
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Leukocyturia
         subjects affected / exposed
    5 / 31 (16.13%)
    4 / 33 (12.12%)
         occurrences all number
    6
    7
    Micturition disorder
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Renal necrosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Renal pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Urinary retention
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Urethral obstruction
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    10 / 31 (32.26%)
    8 / 33 (24.24%)
         occurrences all number
    10
    8
    Diabetes insipidus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 31 (16.13%)
    3 / 33 (9.09%)
         occurrences all number
    5
    3
    Back pain
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 33 (6.06%)
         occurrences all number
    4
    4
    Bone pain
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Chronic kidney disease-mineral and bone disorder
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 33 (0.00%)
         occurrences all number
    3
    0
    Coccydynia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    8 / 31 (25.81%)
    7 / 33 (21.21%)
         occurrences all number
    11
    9
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    5 / 31 (16.13%)
    7 / 33 (21.21%)
         occurrences all number
    6
    10
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Abscess limb
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    6
    Acarodermatitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Arteriovenous fistula site infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Bacterial infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Bacteriuria
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    4
    Body tinea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 33 (6.06%)
         occurrences all number
    6
    4
    Candida infection
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 33 (3.03%)
         occurrences all number
    3
    1
    Cellulitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    6 / 31 (19.35%)
    1 / 33 (3.03%)
         occurrences all number
    6
    1
    Cystitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 33 (3.03%)
         occurrences all number
    3
    1
    Enterobacter sepsis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 33 (6.06%)
         occurrences all number
    2
    5
    Eye infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Eyelid boil
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    2
    2
    Febrile infection
         subjects affected / exposed
    8 / 31 (25.81%)
    6 / 33 (18.18%)
         occurrences all number
    30
    12
    Furuncle
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    10 / 31 (32.26%)
    4 / 33 (12.12%)
         occurrences all number
    13
    5
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Herpes virus infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Human bocavirus infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Implant site infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Infected bite
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    2 / 31 (6.45%)
    5 / 33 (15.15%)
         occurrences all number
    4
    5
    Influenza
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Lice infestation
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Mastoiditis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    27 / 31 (87.10%)
    26 / 33 (78.79%)
         occurrences all number
    68
    80
    Oral candidiasis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 33 (3.03%)
         occurrences all number
    8
    1
    Otitis externa
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    Otitis media
         subjects affected / exposed
    8 / 31 (25.81%)
    6 / 33 (18.18%)
         occurrences all number
    11
    8
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    3 / 31 (9.68%)
    4 / 33 (12.12%)
         occurrences all number
    3
    6
    Periumbilical abscess
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 33 (9.09%)
         occurrences all number
    4
    5
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Pyelonephritis
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 33 (6.06%)
         occurrences all number
    5
    3
    Renal abscess
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    5 / 33 (15.15%)
         occurrences all number
    4
    9
    Rhinitis
         subjects affected / exposed
    23 / 31 (74.19%)
    19 / 33 (57.58%)
         occurrences all number
    63
    42
    Sinusitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Skin candida
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Tinea versicolour
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 31 (19.35%)
    7 / 33 (21.21%)
         occurrences all number
    8
    9
    Urinary tract infection enterococcal
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 33 (3.03%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    12 / 31 (38.71%)
    9 / 33 (27.27%)
         occurrences all number
    33
    24
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Urosepsis
         subjects affected / exposed
    9 / 31 (29.03%)
    6 / 33 (18.18%)
         occurrences all number
    18
    10
    Viral infection
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Calcium deficiency
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Dehydration
         subjects affected / exposed
    11 / 31 (35.48%)
    3 / 33 (9.09%)
         occurrences all number
    15
    3
    Fluid overload
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Fluid intake reduced
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Folate deficiency
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 31 (6.45%)
    5 / 33 (15.15%)
         occurrences all number
    2
    5
    Hypercreatininaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 33 (9.09%)
         occurrences all number
    2
    3
    Hypochloraemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    9 / 33 (27.27%)
         occurrences all number
    1
    9
    Hyponatraemia
         subjects affected / exposed
    5 / 31 (16.13%)
    2 / 33 (6.06%)
         occurrences all number
    9
    4
    Hypophosphataemia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    Hypovitaminosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Hypovolaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency
         subjects affected / exposed
    12 / 31 (38.71%)
    13 / 33 (39.39%)
         occurrences all number
    12
    13
    Metabolic acidosis
         subjects affected / exposed
    3 / 31 (9.68%)
    6 / 33 (18.18%)
         occurrences all number
    3
    6
    Mineral deficiency
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Obesity
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    Pseudogynaecomastia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Vitamin B complex deficiency
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    6 / 31 (19.35%)
    10 / 33 (30.30%)
         occurrences all number
    6
    10
    Zinc deficiency
         subjects affected / exposed
    1 / 31 (3.23%)
    3 / 33 (9.09%)
         occurrences all number
    1
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2011
    • Restrict the study population to children after kidney transplantation • Add Valganciclovir to the study treatment regime • Correct the SAE/pregnancy reporting • Clarify some inconsistencies in the protocol and add some missing information
    28 Nov 2011
    • Extension of study from monocentre to multicentre

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25127887
    http://www.ncbi.nlm.nih.gov/pubmed/33323473
    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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