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    Clinical Trial Results:
    5, 6 or 7 year follow-up control after the SCHEDULE study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE)

    Summary
    EudraCT number
    2016-000404-28
    Trial protocol
    SE   DK  
    Global end of trial date
    25 Sep 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Oct 2018
    First version publication date
    11 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRAD001ANO05
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02864706
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.com
    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
    25 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Renal function as assessed by measured glomerular filtration rate (mGFR)
    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 the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Jan 2016
    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
    Norway: 44
    Country: Number of subjects enrolled
    Sweden: 28
    Country: Number of subjects enrolled
    Denmark: 23
    Worldwide total number of subjects
    95
    EEA total number of subjects
    95
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    86
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    49 Patients were enrolled in the study, but 1 patient withdrew consent in the Everolimus arm.

    Pre-assignment
    Screening details
    The Safety Set had 48 patients in the Everolimus arm and 47 in the Control arm. The Intent to Treat set had 46 in the Everolimus arm and 47 in the Control arm. 48 started the Everolimus arm but 2 patients were excluded from ITT at month 12 due to missing measured GFR.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Everolimus
    Arm description
    All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS and were extended per protocol
    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
    All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS and were extended per proto

    Arm title
    Control
    Arm description
    All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
    Arm type
    Active comparator

    Investigational medicinal product name
    Standard of Care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who were included in core study SCHEDULE (CRAD001ANO02) who started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, CsA was discontinued.

    Number of subjects in period 1
    Everolimus Control
    Started
    48
    47
    Completed
    48
    47

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Everolimus
    Reporting group description
    All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS and were extended per protocol

    Reporting group title
    Control
    Reporting group description
    All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.

    Reporting group values
    Everolimus Control Total
    Number of subjects
    48 47 95
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    43 43 86
        From 65-84 years
    5 4 9
        85 years and over
    0 0 0
    Age Continuous
    Units: Participants
        arithmetic mean (standard deviation)
    50.13 ( 13.43 ) 52.11 ( 11.61 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    13 12 25
        Male
    35 35 70
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    1 2 3
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    0 1 1
        White
    47 44 91
        More than one race
    0 0 0
        Unknown or Not Reported
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Everolimus
    Reporting group description
    All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS and were extended per protocol

    Reporting group title
    Control
    Reporting group description
    All participants who were included in the initial core study SCHEDULE (CRAD001ANO02) who received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.

    Primary: Measured Glomerular Filtration Rate (mGFR)

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    End point title
    Measured Glomerular Filtration Rate (mGFR)
    End point description
    Renal function as assessed by measured Glomerular Filtration Rate (mGFR) (Cr-EDTA or iohexol clearance). Baseline Visit 1 and Patient 4252 excluded from the intent treat analysis set.
    End point type
    Primary
    End point timeframe
    at the 5-7 year follow-up visit
    End point values
    Everolimus Control
    Number of subjects analysed
    45
    46
    Units: mL/min/1.73m2
        least squares mean (standard deviation)
    74.7 ( 23.3 )
    62.4 ( 16.5 )
    Statistical analysis title
    Measured Glomerular Filtration Rate
    Comparison groups
    Everolimus v Control
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0043
    Method
    ANCOVA
    Confidence interval

    Secondary: Progression of Cardiac allograft vasculopathy (CAV) recorded by Intravascular Ultrasound (IVUS)

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    End point title
    Progression of Cardiac allograft vasculopathy (CAV) recorded by Intravascular Ultrasound (IVUS)
    End point description
    Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT) ≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence.
    End point type
    Secondary
    End point timeframe
    within 5-7 years
    End point values
    Everolimus Control
    Number of subjects analysed
    36
    35
    Units: mm
        arithmetic mean (standard deviation)
    0.13 ( 0.15 )
    0.23 ( 0.24 )
    Statistical analysis title
    Cardiac Allograft Vasculopathy (CAV)
    Comparison groups
    Everolimus v Control
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.037
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percent of Participants with Incidence of Coronary Allograft Vasculopathy (CAV)

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    End point title
    Percent of Participants with Incidence of Coronary Allograft Vasculopathy (CAV)
    End point description
    Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT) ≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence.
    End point type
    Secondary
    End point timeframe
    at the 5-7 year follow-up
    End point values
    Everolimus Control
    Number of subjects analysed
    36
    35
    Units: percent of participants
    53
    74
    No statistical analyses for this end point

    Secondary: Myocardial structure and function

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    End point title
    Myocardial structure and function
    End point description
    Myocardial structure and function by echocardiography assessment measured by ventricular end systolic diameter.
    End point type
    Secondary
    End point timeframe
    within 5-7 years
    End point values
    Everolimus Control
    Number of subjects analysed
    46
    47
    Units: cm
    arithmetic mean (standard deviation)
        LVESD (left ventricular end systolic diameter)|
    3.1 ( 0.8 )
    3.1 ( 0.6 )
        LVEDD (left ventricular end diastolic diameter)|
    4.7 ( 0.6 )
    4.9 ( 0.6 )
    No statistical analyses for this end point

    Secondary: Quality of life by SF-36 change from pre-transplantation to 5-7 year follow-up

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    End point title
    Quality of life by SF-36 change from pre-transplantation to 5-7 year follow-up
    End point description
    This Quality of life Short Form Survey with 36 items (Minnesota Living with Heart Failure Questionnaire)was administered to patients pre-transplantation and after transplantation at the 5-7 year visit. This data represents the change. The survey consist of scores on a scale. Each form is scaled from 0 t 100. 0 = maximum disability and 100 equals no disability.
    End point type
    Secondary
    End point timeframe
    at the 5-7 year visit
    End point values
    Everolimus Control
    Number of subjects analysed
    46
    47
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Physical Health Summary|
    16.8 ( 15.0 )
    13.2 ( 13.3 )
        Mental Health Summary|
    10.4 ( 10.5 )
    15.3 ( 15.5 )
        Physical Functioning|
    36.7 ( 38.4 )
    40.8 ( 30.4 )
        Role Physical|
    50.2 ( 32.3 )
    55.1 ( 32.4 )
        Bodily Pain|
    10.3 ( 34.8 )
    7.2 ( 34.1 )
        General Health|
    25.7 ( 26.4 )
    23.4 ( 25.6 )
        Vitality|
    30.0 ( 25.8 )
    28.9 ( 29.0 )
        Social Functioning|
    39.9 ( 31.5 )
    43.9 ( 32.4 )
        Role Emotional|
    23.8 ( 36.7 )
    42.8 ( 46.5 )
        Mental Health|
    8.6 ( 17.2 )
    14.4 ( 25.8 )
    No statistical analyses for this end point

    Secondary: Change from baseline in the Euro Quality of Life 5D

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    End point title
    Change from baseline in the Euro Quality of Life 5D
    End point description
    Change from baseline in Euro Quality of Life-5D from 3 Year Follow-Up to 5 to 7 Year Follow-Up Baseline Visit 1 (ITT Set) The EQ-5D is a self-reported questionnaire that describes a respondent's health using a descriptive system comprised of five items, each representing a different health dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity.
    End point type
    Secondary
    End point timeframe
    Baseline, 5-7 year visit
    End point values
    Everolimus Control
    Number of subjects analysed
    46
    46
    Units: scores on the scale
        arithmetic mean (standard deviation)
    0.2323 ( 0.3849 )
    0.2982 ( 0.3274 )
    No statistical analyses for this end point

    Secondary: Change from baseline in visual analog scale (VAS)

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    End point title
    Change from baseline in visual analog scale (VAS)
    End point description
    Change in visual analog scale (VAS) from baseline to the 5 to 7 Year follow up visit. 0 is no pain; and 10 is the worst possible pain
    End point type
    Secondary
    End point timeframe
    baseline, at the 5-7 year visit
    End point values
    Everolimus Control
    Number of subjects analysed
    46
    47
    Units: mm
        arithmetic mean (standard deviation)
    35.6 ( 26.9 )
    34.0 ( 32.0 )
    No statistical analyses for this end point

    Secondary: Number of participants with Beck Depression Inventory (BDI)

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    End point title
    Number of participants with Beck Depression Inventory (BDI)
    End point description
    Beck Depression Inventory (BDI) Score has the following categories of depression. Normal, Mild, Moderate Severe and Missing.
    End point type
    Secondary
    End point timeframe
    at the 5-7 year visit
    End point values
    Everolimus Control
    Number of subjects analysed
    46
    47
    Units: participants
        Normal|
    15
    13
        Mild|
    6
    4
        Moderate|
    2
    5
        Severe|
    1
    0
        Missing|
    3
    5
    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
    19.1
    Reporting groups
    Reporting group title
    Everolimus
    Reporting group description
    Everolimus

    Reporting group title
    Control
    Reporting group description
    Control

    Serious adverse events
    Everolimus Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 48 (54.17%)
    18 / 47 (38.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    2 / 2
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hernia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Heart transplant rejection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    11 / 11
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    8 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    12 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 0
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    13 / 48 (27.08%)
    3 / 47 (6.38%)
         occurrences causally related to treatment / all
    72 / 72
    52 / 52
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    12 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    13 / 13
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    12 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    6 / 6
    27 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Everolimus Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 48 (31.25%)
    4 / 47 (8.51%)
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    5 / 48 (10.42%)
    0 / 47 (0.00%)
         occurrences all number
    21
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 48 (8.33%)
    3 / 47 (6.38%)
         occurrences all number
    23
    24
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    8 / 48 (16.67%)
    2 / 47 (4.26%)
         occurrences all number
    46
    14
    Sepsis
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 47 (0.00%)
         occurrences all number
    16
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2016
    New global study code Ensure that data from already occurred 5 or 6 years routine annual visits can be collected.
    07 Jul 2016
    Updated according to comments from the Danish HA to initial protocol v2.0 (Definitions for (S)AE, ADR, SUSAR)

    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.
    There is no investigational medicinal product (IMP). This study is a single follow-up visit. Hence patients’ first and last visit dates are the same. And thus, there are no Adverse Events.
    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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