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    Clinical Trial Results:
    A 24-month, multi-center, single arm, prospective study to evaluate renal function, efficacy, safety and tolerability of everolimus in combination with reduced exposure cyclosporine or tacrolimus in paediatric liver transplant recipients

    Summary
    EudraCT number
    		 2011-003069-14
    Trial protocol
    		 HU   SE   DE   ES   GB   DK   IT   BE   FR  
    Global end of trial date
    01 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2016
    First version publication date
    16 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRAD001H2305
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01598987
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000019-PIP06-09
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) estimated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009) from start to Month 12 of an everolimus based regimen
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during he conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    56
    EEA total number of subjects
    43
    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)
    25
    Children (2-11 years)
    26
    Adolescents (12-17 years)
    5
    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
    		 -

    Pre-assignment
    Screening details
    		 Overall 62 patients were screened prior to the data monitoring committee (DMC) recommendation to terminate enrolment. Six patients were screen failures. The other 56 patients were included and treated.

    Period 1
    Period 1 title
    Period up to Month 12
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Everolimus based regimen
    Arm description
    		 Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC). The dosing schedule was twice daily, 12 hours apart.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    RAD001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Everolimus 0.10 and 0.25 mg dispersible tablets and 0.25, 0.50, 0.75 and 1.0 mg tablets were provided for oral administration. At the start of everolimus treatment regimen, pediatric transplant recipients received a starting dose of 0.8 mg/m2/dose in combination with cyclosporine or 2.0 mg/m2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/mL.

    Number of subjects in period 1
    		Everolimus based regimen
    Started
    56
    Completed
    50
    Not completed
    6
         Consent withdrawn by subject
    4
         Administrative problems
    2
    Period 2
    Period 2 title
    Period up to 24 month
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Everolimus based regimen
    Arm description
    		 Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC). The dosing schedule was twice daily, 12 hours apart.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    RAD001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Everolimus 0.10 and 0.25 mg dispersible tablets and 0.25, 0.50, 0.75 and 1.0 mg tablets were provided for oral administration. At the start of everolimus treatment regimen, pediatric transplant recipients received a starting dose of 0.8 mg/m2/dose in combination with cyclosporine or 2.0 mg/m2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/mL.

    Number of subjects in period 2
    		Everolimus based regimen
    Started
    50
    Completed
    48
    Not completed
    2
         Consent withdrawn by subject
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Everolimus based regimen
    Reporting group description
    		 Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC). The dosing schedule was twice daily, 12 hours apart.

    Reporting group values
    		 Everolimus based regimen Total
    Number of subjects
    		 56 56
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 25 25
        Children (2-11 years)
    		 26 26
        Adolescents (12-17 years)
    		 5 5
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.9 ( 4.59 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 25 25
        Male
    		 31 31

    End points

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    End points reporting groups
    Reporting group title
    Everolimus based regimen
    Reporting group description
    		 Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC). The dosing schedule was twice daily, 12 hours apart.
    Reporting group title
    Everolimus based regimen
    Reporting group description
    		 Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC). The dosing schedule was twice daily, 12 hours apart.

    Subject analysis set title
    <=5% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Height

    Subject analysis set title
    >5% - 25% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Height

    Subject analysis set title
    >25% - 50% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Height

    Subject analysis set title
    >50% - 75% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Height

    Subject analysis set title
    >75% - 95% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Height

    Subject analysis set title
    >95% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Height

    Subject analysis set title
    Total
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles at 12 months

    Subject analysis set title
    <=5% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Weight

    Subject analysis set title
    >5% - 25% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Weight

    Subject analysis set title
    >25% - 50% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Weight

    Subject analysis set title
    >50% - 75% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Weight

    Subject analysis set title
    >75% - 95% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Weight

    Subject analysis set title
    >95% percentile
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Growth percentile category - Weight

    Subject analysis set title
    Total
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles at 12 months

    Primary: Change from Baseline in Estimated Glomerular Filtration Rate - Month 12

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate - Month 12 [1]
    End point description
    Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) estimated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.
    End point type
    Primary
    End point timeframe
    Baseline, Month 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this end point.
    End point values
    		 Everolimus based regimen
    Number of subjects analysed
    50
    Units: mL/min/1.73m^2
        arithmetic mean (standard deviation)
    6.2 ( 19.52 )
    No statistical analyses for this end point

    Secondary: Kaplan-Meier Estimates for Failure rates of Efficacy Endpoints

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    End point title
    		 Kaplan-Meier Estimates for Failure rates of Efficacy Endpoints
    End point description
    The proportion of patients with composite efficacy failure (treated biopsy proven acute rejection[tBPAR], graft loss [GL] , death [D]) before/at Month 12 and Month 24, estimated with Kaplan-Meier (KM) methods and the proportion of patients who experienced any of the components of composite efficacy failure (tBPAR, GL, D) before/at Month 12 and Month 24, separately for each component. AR: acute rejection; BPAR: biopsy proven acute rejection. Rate = Kaplan-Meier estimate for failure in %; CI = confidence interval for failure rate.
    End point type
    Secondary
    End point timeframe
    At 12-month and 24-month after start of study drug
    End point values
    		 Everolimus based regimen
    Number of subjects analysed
    56
    Units: Percentages
    number (confidence interval 80%)
        Month 12: tBPAR,GL,or D
    1.9 (0 to 4.2)
        Month 12: tBPAR,GL,D,or loss to follow-up
    1.9 (0 to 4.2)
        Month 12: Treated BPAR
    1.9 (0 to 4.2)
        Month 12: Graft loss
    0 (0 to 0)
        Month 12: Death
    0 (0 to 0)
        Month 12: Graft loss or death
    0 (0 to 0)
        Month 12: BPAR
    3.7 (0.4 to 7)
        Month 12: Treated AR
    3.6 (0.4 to 6.9)
        Month 24: tBPAR,GL,or D
    5.9 (0.3 to 11.5)
        Month 24: tBPAR,GL,D,or loss to follow-up
    9.7 (2.5 to 16.9)
        Month 24: Treated BPAR
    5.9 (0.3 to 11.5)
        Month 24: Graft Loss
    0 (0 to 0)
        Month 24: Death
    0 (0 to 0)
        Month 24: Graft loss or death
    0 (0 to 0)
        Month 24: BPAR
    11.9 (4.2 to 19.6)
        Month 24: Treated AR
    7.7 (1.7 to 13.6)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Estimated Glomerular Filtration Rate - Month 24

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate - Month 24
    End point description
    Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) estimated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 24.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 24
    End point values
    		 Everolimus based regimen
    Number of subjects analysed
    50
    Units: mL/min/1.73m2
        arithmetic mean (standard deviation)
    4.5 ( 19.55 )
    No statistical analyses for this end point

    Secondary: Growth development - Height at Baseline and Month 12

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    End point title
    		 Growth development - Height at Baseline and Month 12
    End point description
    Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 <=5% percentile >5% - 25% percentile >25% - 50% percentile >50% - 75% percentile >75% - 95% percentile >95% percentile Total
    Number of subjects analysed
    16
    15
    6
    7
    4
    2
    50
    Units: Percentages
    number (not applicable)
        Decrease
    0
    26.7
    16.7
    14.3
    25
    0
    14
        No Change
    68.8
    20
    33.3
    28.6
    50
    100
    44
        Increase >3 to 5%
    12.5
    6.7
    0
    0
    25
    0
    8
        Increase >5 to 10%
    0
    20
    16.7
    14.3
    0
    0
    10
        Increase >10%
    18.8
    26.7
    33.3
    42.9
    0
    0
    24
    No statistical analyses for this end point

    Secondary: Growth development - Weight at Baseline and Month 12

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    End point title
    		 Growth development - Weight at Baseline and Month 12
    End point description
    Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 12
    End point values
    		 <=5% percentile >5% - 25% percentile >25% - 50% percentile >50% - 75% percentile >75% - 95% percentile >95% percentile Total
    Number of subjects analysed
    15
    10
    7
    11
    6
    1
    22
    Units: Percentages
    number (not applicable)
        Decrease
    0
    20
    42.9
    72.9
    16.7
    0
    28
        No Change
    33.3
    20
    0
    18.2
    33.3
    100
    24
        Increase >3 to 5%
    0
    0
    0
    0
    16.7
    0
    2
        Increase >5 to 10%
    26.7
    0
    0
    9.1
    0
    0
    10
        Increase >10%
    40
    60
    57.1
    0
    33.3
    0
    36
    No statistical analyses for this end point

    Secondary: Growth development - Weight at Baseline and Month 24

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    End point title
    		 Growth development - Weight at Baseline and Month 24
    End point description
    Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 24
    End point values
    		 <=5% percentile >5% - 25% percentile >25% - 50% percentile >50% - 75% percentile >75% - 95% percentile >95% percentile Total
    Number of subjects analysed
    6
    5
    2
    8
    0 [2]
    1
    22
    Units: Percentages
    number (not applicable)
        Decrease
    0
    40
    100
    12.5
    0
    22.7
        No Change
    50
    0
    0
    25
    100
    27.3
        Increase >3 to 5%
    16.7
    0
    0
    12.5
    0
    9.1
        Increase >5 to 10%
    16.7
    20
    0
    12.5
    0
    13.6
        Increase >10%
    16.7
    40
    0
    37.5
    0
    27.3
    Notes
    [2] - No patients were analyzed.
    No statistical analyses for this end point

    Secondary: Growth development - Height at Baseline and Month 24

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    End point title
    		 Growth development - Height at Baseline and Month 24
    End point description
    Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts. Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 24
    End point values
    		 <=5% percentile >5% - 25% percentile >25% - 50% percentile >50% - 75% percentile >75% - 95% percentile >95% percentile Total
    Number of subjects analysed
    6
    8
    3
    2
    2
    1
    22
    Units: Percentages
    number (not applicable)
        Decrease
    0
    12.5
    33.3
    0
    0
    0
    9
        No Change
    50
    12.5
    0
    0
    50
    100
    27.3
        Increase >3 to 5%
    33.3
    12.5
    0
    0
    50
    0
    18.2
        Increase >5 to 10%
    0
    0
    33.3
    0
    0
    0
    4.5
        Increase >10%
    16.7
    62.5
    33.3
    100
    0
    0
    40.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    All Patients
    Reporting group description
    		 All Patients

    Serious adverse events
    		 All Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 56 (76.79%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences causally related to treatment / all
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    9 / 56 (16.07%)
         occurrences causally related to treatment / all
    6 / 10
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transplant rejection
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stridor
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Food aversion
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Body temperature increased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug level increased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Liver function test increased
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Biliary anastomosis complication
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Complications of transplanted liver
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transplant failure
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Splenic lesion
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aphthous ulcer
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Internal hernia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cholangitis
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatic vein occlusion
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Portal fibrosis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dermal cyst
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Swelling face
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Adenoviral upper respiratory infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Alpha haemolytic streptococcal infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Epstein-Barr viraemia
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis sapovirus
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral viral infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 56 (12.50%)
         occurrences causally related to treatment / all
    5 / 7
         deaths causally related to treatment / all
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Puncture site infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Scarlet fever
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 56 (91.07%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Pain
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    22 / 56 (39.29%)
         occurrences all number
    41
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 56 (12.50%)
         occurrences all number
    8
    Epistaxis
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Oropharyngeal pain
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Blood creatine phosphokinase increased
         subjects affected / exposed
    7 / 56 (12.50%)
         occurrences all number
    7
    Hepatic enzyme increased
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Fall
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    9
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    7
    Neutropenia
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    5
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 56 (12.50%)
         occurrences all number
    10
    Abdominal pain upper
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    22 / 56 (39.29%)
         occurrences all number
    36
    Mouth ulceration
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    8
    Nausea
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    7
    Stomatitis
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    15 / 56 (26.79%)
         occurrences all number
    22
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    7
    Conjunctivitis
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    6
    Cytomegalovirus viraemia
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    7
    Diarrhoea infectious
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    5
    Ear infection
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    11
    Epstein-Barr viraemia
         subjects affected / exposed
    10 / 56 (17.86%)
         occurrences all number
    14
    Epstein-Barr virus infection
         subjects affected / exposed
    7 / 56 (12.50%)
         occurrences all number
    10
    Eye infection
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Gastroenteritis
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    8
    Influenza
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Nasopharyngitis
         subjects affected / exposed
    15 / 56 (26.79%)
         occurrences all number
    35
    Otitis media
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    6
    Tonsillitis
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 56 (25.00%)
         occurrences all number
    17
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2014
    The main purpose of this amendment was a) to introduce a 12 Month analysis in a subset of at least 20 patients for the purpose of regulatory data submission, and b) to introduce a standardized definition for the assessment of NODM which was applied to all ongoing and new RAD001 clinical trials.
    13 Feb 2015
    The main purpose of this amendment was to implement CRAD001H2305 DMC recommendations. DMC recommended to keep the enrollment closed (due to high rate of post-transplant lymphoproliferative disorder, high rate of related serious infections leading to prolonged hospitalization and high rate of premature discontinuation of study medication) and discontinue the study medication in patients younger than 7 years of age and switch those patients to standard of care immunosuppressive treatment. All patients who discontinued study medication, regardless of age, were required to remain in the study for safety follow-up up to 24 months, as per protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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