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    Clinical Trial Results:
    A 2-arm, prospective, randomized, controlled, open-label, 12 month Phase III trial to evaluate the efficacy regarding renal function of everolimus in combination with a centre specific standard immunosuppressive regimen consisting of CNI, purinantagonists and steroids versus a standard triple immunosuppressive regimen in lung transplant recipients.

    Summary
    EudraCT number
    		 2011-001539-21
    Trial protocol
    		 DE  
    Global end of trial date
    05 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2017
    First version publication date
    31 Dec 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CRAD001ADE36
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01404325
    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)
    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
    Interim
    Date of interim/final analysis
    05 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate that an everolimus-based, quadruple immunosuppressive regimen had superior efficacy on renal function compared with a calcineurin inhibitor (CNI)-based triple immunosuppressive regimen as measured by calculated GFR (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months after randomization in lung transplant recipients.
    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
    01 Feb 2012
    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: 130
    Worldwide total number of subjects
    130
    EEA total number of subjects
    130
    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)
    121
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 232 patients who were de novo lung transplant recipients were planned for enrolling into the study. A total of 130 patients were actually randomized with 67 patients randomized to the quadruple low-level treatment arm and 63 patients randomized to the center-specific triple treatment arm.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Quadruple low level IS regimen
    Arm description
    		 quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids
    Arm type
    		 Experimental

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    RAD001
    Other name
    Certican
    Pharmaceutical forms
    Tablet, Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Everolimus (0.25mg, 0.5mg, 0.75mg or 1.0mg) oral tablets or (0.1mg) oral dispersible tablets administered as a suspension daily dosing according to blood levels serum trough level: 4 +/- 1 ng/mL

    Investigational medicinal product name
    Cyclosporine A
    Investigational medicinal product code
    Other name
    Sandimmun® Optoral
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cyclosporine A (10 mg, 25 mg, 50 mg or 100 mg) oral capsules daily dosing according to blood levels serum trough level: 50 +/- 25 ng/mL

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tacrolimus (0.5 mg, 1 mg or 5 mg,) oral capsules as a suspension daily dosing according to blood levels serum trough level: 3-5 ng/mL

    Investigational medicinal product name
    Mycophenolate mofetil (MMF)
    Investigational medicinal product code
    Other name
    CellCept
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolate mofetil 250mg oral capsule or 500mg oral tablets daily dosing max 2000 mg/day

    Investigational medicinal product name
    Mycophenolic acid
    Investigational medicinal product code
    Other name
    Myfortic
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolic acid 180mg or 360mg oral tablets daily dosing max 1440 mg/day

    Investigational medicinal product name
    Azathioprine
    Investigational medicinal product code
    Other name
    Imurek
    Pharmaceutical forms
    Tablet, Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Oral use
    Dosage and administration details
    Azathioprine 25mg or 50mg oral tablets daily or 50mg powder for infusion dosing max 2mg/kg/day

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone oral tablets daily dosing ≤ 0.15 mg/kg

    Arm title
    		 Centre specific triple IS regimen
    Arm description
    		 centre specific CNI-based triple drug immunosuppression (IS)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cyclosporine A
    Investigational medicinal product code
    Other name
    Sandimmun® Optoral
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cyclosporine A (10 mg, 25 mg, 50 mg or 100 mg) oral capsules daily dosing according to blood levels serum trough level: ≥ 100 ng/mL

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tacrolimus (0.5 mg, 1 mg or 5 mg,) oral capsules as a suspension daily dosing according to blood levels serum trough level: > 5 ng/mL

    Investigational medicinal product name
    Mycophenolate mofetil (MMF)
    Investigational medicinal product code
    Other name
    CellCept
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolate mofetil 250mg oral capsule or 500mg oral tablets daily dosing max 2000 mg/day dosage was center-specific

    Investigational medicinal product name
    Mycophenolic acid
    Investigational medicinal product code
    Other name
    Myfortic
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Mycophenolic acid 180mg or 360mg oral tablets daily dosing max 1440 mg/day dosage was center-specific

    Investigational medicinal product name
    Azathioprine
    Investigational medicinal product code
    Other name
    Imurek
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Azathioprine 25mg or 50mg oral tablets daily or 50mg powder for infusion dosing max 2mg/kg/day dosage was center-specific

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone oral tablets daily dosing ≤ 0.2 mg/kg

    Number of subjects in period 1
    		Quadruple low level IS regimen Centre specific triple IS regimen
    Started
    67
    63
    Completed
    63
    61
    Not completed
    4
    2
         Adverse event, serious fatal
    2
    -
         non-specified reason
    -
    2
         Graft loss/Retransplantation
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Quadruple low level IS regimen
    Reporting group description
    		 quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids

    Reporting group title
    Centre specific triple IS regimen
    Reporting group description
    		 centre specific CNI-based triple drug immunosuppression (IS)

    Reporting group values
    		 Quadruple low level IS regimen Centre specific triple IS regimen Total
    Number of subjects
    		 67 63 130
    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)
    		 64 57 121
        From 65-84 years
    		 3 6 9
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.9 ( 9.5 ) 54.2 ( 9.2 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 27 22 49
        Male
    		 40 41 81

    End points

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    End points reporting groups
    Reporting group title
    Quadruple low level IS regimen
    Reporting group description
    		 quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids

    Reporting group title
    Centre specific triple IS regimen
    Reporting group description
    		 centre specific CNI-based triple drug immunosuppression (IS)

    Primary: Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months

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    End point title
    		 Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months
    End point description
    Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1
    End point type
    Primary
    End point timeframe
    Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mL/min
        least squares mean (confidence interval 95%)
    64.5 (59.4 to 69.6)
    54.6 (49.5 to 59.7)
    Statistical analysis title
    		 cGFR according to CKD EPI at 12 months
    Comparison groups
    Centre specific triple IS regimen v Quadruple low level IS regimen
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12

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    End point title
    		 Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12
    End point description
    Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9 and 12. The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mL/min
    arithmetic mean (standard deviation)
        Month 1
    73.5 ( 13.9 )
    67.1 ( 12.4 )
        Month 3
    70.4 ( 13.3 )
    64.3 ( 12.7 )
        Month 6
    69.2 ( 15.5 )
    63.1 ( 15.0 )
        Month 9
    69.0 ( 16.3 )
    62.3 ( 14.8 )
        Month 12
    68.3 ( 16.3 )
    61.2 ( 14.3 )
    No statistical analyses for this end point

    Secondary: Calculated Glomerular Filtration Rate (cGFR) according to Cystatin C-based Hoek’s formula at Month 1, 3, 6, 9, 12

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    End point title
    		 Calculated Glomerular Filtration Rate (cGFR) according to Cystatin C-based Hoek’s formula at Month 1, 3, 6, 9, 12
    End point description
    Calculated Glomerular Filtration Rate (cGFR) according to Cystatin C-based Hoek’s formula at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mL/min
    arithmetic mean (standard deviation)
        Month 1
    68.5 ( 14.6 )
    61.8 ( 12.8 )
        Month 3
    65.7 ( 15.2 )
    60.3 ( 10.6 )
        Month 6
    63.0 ( 15.1 )
    58.7 ( 12.2 )
        Month 9
    61.8 ( 14.1 )
    57.7 ( 12.8 )
        Month 12
    60.8 ( 14.2 )
    57.5 ( 14.1 )
    No statistical analyses for this end point

    Secondary: Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12

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    End point title
    		 Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12
    End point description
    Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 cGFR (in mL/min/1.73 m2) = 186.3*(C-1.154)*(A-0.203)*G*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mL/min
    arithmetic mean (standard deviation)
        Month 1
    72.0 ( 13.5 )
    65.8 ( 11.8 )
        Month 3
    68.7 ( 12.2 )
    63.3 ( 12.3 )
        Month 6
    67.6 ( 14.1 )
    62.3 ( 15.0 )
        Month 9
    67.4 ( 14.9 )
    61.7 ( 15.1 )
        Month 12
    67.0 ( 14.8 )
    60.5 ( 14.4 )
    No statistical analyses for this end point

    Secondary: Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 1, 3, 6, 9, 12

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    End point title
    		 Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 1, 3, 6, 9, 12
    End point description
    Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 1, 3, 6, 9, 12 For men: GFR=(140 -Age) x Body weight[kg] / 72 x Serum Creatinine [mg/dl] For women: GFR=0.85 (140 -Age) x Body weight[kg] / 72 x Serum Creatinine [mg/dl]
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mL/min
    arithmetic mean (standard deviation)
        Month 1
    78.6 ( 19.2 )
    72.1 ( 14.9 )
        Month 3
    76.1 ( 17.6 )
    70.1 ( 16.0 )
        Month 6
    76.2 ( 19.3 )
    69.1 ( 17.5 )
        Month 9
    76.2 ( 20.1 )
    69.0 ( 18.2 )
        Month 12
    76.2 ( 20.6 )
    68.4 ( 17.8 )
    No statistical analyses for this end point

    Secondary: Incidence of patients experiencing a decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/min from Baseline to Month 6 and 12.

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    End point title
    		 Incidence of patients experiencing a decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/min from Baseline to Month 6 and 12.
    End point description
    Incidence of patients experiencing a decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/min from Baseline to Month 6 and 12calculated by the CKD-EPI method. Participants are counted in each decline level observed for that participant; this means participants may be counted in more than 1 decline level.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: count of incidences
        Up to Month 6: < 10 mL/min
    28
    44
        Up to Month 6: 10 - < 15 mL/min
    9
    18
        Up to Month 6: 15 - < 20 mL/min
    6
    11
        Up to Month 6: 20 - < 25 mL/min
    2
    7
        Up to Month 6: > 25 mL/min
    3
    7
        Up to Month 12: < 10 mL/min
    36
    53
        Up to Month 12: 10 - < 15 mL/min
    10
    27
        Up to Month 12: 15 - < 20 mL/min
    8
    18
        Up to Month 12: 20 - < 25 mL/min
    8
    9
        Up to Month 12: > 25 mL/min
    7
    9
    No statistical analyses for this end point

    Secondary: Incidence of renal replacement therapy at Month 6 and Month 12

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    End point title
    		 Incidence of renal replacement therapy at Month 6 and Month 12
    End point description
    Incidence of renal replacement therapy at Month 6 and Month 12: There were no incidences in either group where renal replacement therapy was required
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: count of incidences
        up to Month 6
    0
    0
        up to Month 12
    0
    0
    No statistical analyses for this end point

    Secondary: Time to renal replacement therapy at Month 6 and Month 12

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    End point title
    		 Time to renal replacement therapy at Month 6 and Month 12
    End point description
    Time to renal replacement therapy at Month 6 and Month 12: There were no incidences in either group where renal replacement therapy was required
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: days
    Notes
    [1] - There were no incidences in either group where renal replacement therapy was required
    [2] - There were no incidences in either group where renal replacement therapy was required
    No statistical analyses for this end point

    Secondary: Incidence of acute rejection episodes at Month 6 and Month 12

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    End point title
    		 Incidence of acute rejection episodes at Month 6 and Month 12
    End point description
    Incidence of acute rejection episodes at Month 6 and Month 12. This table counts multiple occurrences of rejection in the same patient as different incidents. Every incident is associated with both an A and a B classification.
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: count of incidences
        Up to 6 months: Classification A
    11
    13
        Up to 6 months: Classification B
    11
    13
        6 to 12 months: Classification A
    10
    9
        6 to 12 months: Classification B
    10
    9
    No statistical analyses for this end point

    Secondary: Incidence of graft loss/re-transplantation at Month 6 and Month 12

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    End point title
    		 Incidence of graft loss/re-transplantation at Month 6 and Month 12
    End point description
    Incidence of graft loss/re-transplantation at Month 6 and Month 12
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: count of incidences
        Month 6
    0
    0
        Month 12
    1
    1
    No statistical analyses for this end point

    Secondary: Incidence of Bronchiolitis obliterans syndrome (BOS) at Month 6 and Month 12

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    End point title
    		 Incidence of Bronchiolitis obliterans syndrome (BOS) at Month 6 and Month 12
    End point description
    Incidence of Bronchiolitis obliterans syndrome (BOS) at Month 6 and Month 12
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: count of incidences
        Month 6 - Total (all grades)
    66
    61
        Month 12 - Total (all grades)
    66
    61
    No statistical analyses for this end point

    Secondary: Incidence of death at Month 6 and Month 12

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    End point title
    		 Incidence of death at Month 6 and Month 12
    End point description
    Incidence of death at Month 6 and Month 12
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: number of events
        Month 6
    0
    0
        Month 12
    3
    1
    No statistical analyses for this end point

    Secondary: Quality of Life (QoL, SF36) at Month 6 and Month 12

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    End point title
    		 Quality of Life (QoL, SF36) at Month 6 and Month 12
    End point description
    Quality of Life (QoL, SF36) at Month 6 and Month 12 Scores can range from a minimum of 0 (maximum disability) to a maximum of 100 (no disability).
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: score
    arithmetic mean (standard deviation)
        Month 6: Physical component summary score
    46.9 ( 7.6 )
    48.9 ( 7.3 )
        Month 6: Mental component summary score
    51.5 ( 10.8 )
    52.6 ( 8.1 )
        Month 6: Physical functioning
    78.8 ( 20.9 )
    84.1 ( 16.8 )
        Month 6: Role-Physical
    71.1 ( 23.2 )
    77.1 ( 24.2 )
        Month 6: Bodily pain
    76.4 ( 27.9 )
    81.3 ( 23.4 )
        Month 6: General health perception
    65.4 ( 19.2 )
    70.6 ( 19.9 )
        Month 6: Vitality
    67.4 ( 18.0 )
    70.0 ( 14.6 )
        Month 6:Social functioning
    84.1 ( 22.6 )
    88.9 ( 17.6 )
        Month 6: Role-Emotional
    84.7 ( 22.4 )
    84.8 ( 17.9 )
        Month 6: Mental health
    78.5 ( 17.2 )
    81.0 ( 12.8 )
        Month 12: Physical component summary score
    47.2 ( 8.8 )
    47.7 ( 7.1 )
        Month 12: Mental component summary score
    49.7 ( 11.8 )
    53.8 ( 9.1 )
        Month 12: Physical functioning
    77.4 ( 21.8 )
    82.5 ( 20.0 )
        Month 12: Role-Physical
    68.3 ( 26.8 )
    78.0 ( 22.9 )
        Month 12: Bodily Pain
    76.8 ( 27.0 )
    80.1 ( 22.7 )
        Month 12: General health perception
    66.7 ( 17.3 )
    65.8 ( 20.3 )
        Month 12: Vitality
    65.7 ( 19.4 )
    69.9 ( 17.5 )
        Month 12: Social functioning
    82.3 ( 23.0 )
    90.5 ( 16.1 )
        Month 12: Role-Emotional
    79.4 ( 27.3 )
    86.2 ( 20.5 )
        Month 12: Mental health
    75.4 ( 18.2 )
    81.8 ( 14.8 )
    No statistical analyses for this end point

    Secondary: Exercise capacity 6-Minute walk test(6MWT) at Month 6 and Month 12

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    End point title
    		 Exercise capacity 6-Minute walk test(6MWT) at Month 6 and Month 12
    End point description
    Exercise capacity (6MWT) at Month 6 and Month 12 The higher the Borg score implies increased shortness of breath and/or increased fatigue.
    End point type
    Secondary
    End point timeframe
    Month 6, Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: Score
    arithmetic mean (standard deviation)
        Month 6-Borg score - Before start of test
    0.47 ( 0.78 )
    0.39 ( 0.77 )
        Month 6-Borg score - At end of test
    1.75 ( 1.58 )
    1.64 ( 1.31 )
        Month 12-Borg score - Before start of test
    0.38 ( 0.94 )
    0.42 ( 0.79 )
        Month 12-Borg score - At end of test
    2.08 ( 1.58 )
    2.06 ( 1.85 )
    No statistical analyses for this end point

    Secondary: Incidence of treated arterial hypertension up to Month 12

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    End point title
    		 Incidence of treated arterial hypertension up to Month 12
    End point description
    Incidence of treated of arterial hypertension up to Month 12
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: number of event
        Month 1
    2
    1
        Month 3
    2
    1
        Month 6
    2
    1
        Month 9
    3
    1
        Month 12
    4
    1
    No statistical analyses for this end point

    Secondary: Incidence of Diabetes Mellitus up to Month 12

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    End point title
    		 Incidence of Diabetes Mellitus up to Month 12
    End point description
    Incidence of Diabetes Mellitus up to Month 12
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: number of events
        Month 1
    0
    0
        Month 3
    0
    0
        Month 6
    0
    1
        Month 9
    1
    1
        Month 12
    1
    1
    No statistical analyses for this end point

    Secondary: Trough levels of everolimus at Month 1, 3, 6, 9, 12

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    End point title
    		 Trough levels of everolimus at Month 1, 3, 6, 9, 12 [3]
    End point description
    Trough levels of everolimus at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This Endpoint is on everolimus levels only
    End point values
    		 Quadruple low level IS regimen
    Number of subjects analysed
    67
    Units: ng/mL
    arithmetic mean (standard deviation)
        Month 1 n=66
    4.2 ( 1.4 )
        Month 3 n=61
    4.4 ( 1.2 )
        Month 6 n=58
    4.1 ( 1.2 )
        Month 9 n=52
    4.5 ( 1.6 )
        Month 12 n=50
    4.3 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Adherence to target ranges of everolimus at Month 1, 3, 6, 9, 12

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    End point title
    		 Adherence to target ranges of everolimus at Month 1, 3, 6, 9, 12 [4]
    End point description
    Adherence to target ranges of everolimus at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This Endpoint is on everolimus levels only
    End point values
    		 Quadruple low level IS regimen
    Number of subjects analysed
    67
    Units: participant adherence
        Month 1 Below Target Range
    10
        Month 1 Within Target Range
    42
        Month 1 Above Target Range
    14
        Month 3 Below Target Range
    5
        Month 3 Within Target Range
    41
        Month 3 Above Target Range
    15
        Month 6 Below Target Range
    7
        Month 6 Within Target Range
    39
        Month 6 Above Target Range
    12
        Month 9 Below Target Range
    5
        Month 9 Within Target Range
    34
        Month 9 Above Target Range
    13
        Month 12 Below Target Range
    3
        Month 12 Within Target Range
    38
        Month 12 Above Target Range
    9
    No statistical analyses for this end point

    Secondary: Trough levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12

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    End point title
    		 Trough levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
    End point description
    Trough levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: ng/mL
    arithmetic mean (standard deviation)
        Month 1 n=21, 16
    61 ( 21.83 )
    106 ( 21.25 )
        Month 3 n=20, 14
    59.65 ( 20.43 )
    109 ( 24.95 )
        Month 6 n= 20, 14
    58.50 ( 12.84 )
    103 ( 32.95 )
        Month 9 n=17, 13
    57.59 ( 23.26 )
    107 ( 29.13 )
        Month 12 n=21, 13
    69.33 ( 48.41 )
    108 ( 27.82 )
    No statistical analyses for this end point

    Secondary: Adherence to target ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12

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    End point title
    		 Adherence to target ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
    End point description
    Adherence to target ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: participant adherence
        Month 1 Below Target Range
    0
    8
        Month 1 Within Target Range
    18
    8
        Month 1 Above Target Range
    3
    0
        Month 3 Below Target Range
    0
    4
        Month 3 Within Target Range
    18
    10
        Month 3 Above Target Range
    2
    0
        Month 6 Below Target Range
    0
    6
        Month 6 Within Target Range
    18
    8
        Month 6 Above Target Range
    2
    0
        Month 9 Below Target Range
    0
    4
        Month 9 Within Target Range
    16
    9
        Month 9 Above Target Range
    1
    0
        Month 12 Below Target Range
    0
    3
        Month 12 Within Target Range
    16
    10
        Month 12 Above Target Range
    5
    0
    No statistical analyses for this end point

    Secondary: Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12

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    End point title
    		 Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12
    End point description
    Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: ng/mL
    arithmetic mean (standard deviation)
        Month 1 n=44, 45
    5.07 ( 1.80 )
    10.44 ( 2.73 )
        Month 3 n=44, 47
    5.18 ( 2.02 )
    10.53 ( 2.88 )
        Month 6 n= 40, 46
    4.70 ( 1.98 )
    10.09 ( 3.37 )
        Month 9 n=38, 46
    5.78 ( 4.18 )
    10.67 ( 3.44 )
        Month 12 n=41, 47
    5.19 ( 2.36 )
    9.66 ( 3.01 )
    No statistical analyses for this end point

    Secondary: Adherence to target ranges of Tacrolimus at Month 1, 3, 6, 9, 12

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    End point title
    		 Adherence to target ranges of Tacrolimus at Month 1, 3, 6, 9, 12
    End point description
    Adherence to target ranges of Tacrolimus at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: participant adherence
        Month 1 Below Target Range
    3
    0
        Month 1 Within Target Range
    24
    45
        Month 1 Above Target Range
    17
    0
        Month 3 Below Target Range
    3
    0
        Month 3 Within Target Range
    23
    47
        Month 3 Above Target Range
    18
    0
        Month 6 Below Target Range
    5
    1
        Month 6 Within Target Range
    23
    45
        Month 6 Above Target Range
    12
    0
        Month 9 Below Target Range
    2
    0
        Month 9 Within Target Range
    18
    46
        Month 9 Above Target Range
    18
    0
        Month 12 Below Target Range
    3
    0
        Month 12 Within Target Range
    23
    47
        Month 12 Above Target Range
    15
    0
    No statistical analyses for this end point

    Secondary: Incidence of bacterial, viral, and fungal infections at Month 12

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    End point title
    		 Incidence of bacterial, viral, and fungal infections at Month 12
    End point description
    Incidence of bacterial, viral, and fungal infections at Month 12
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: number of incidences
        Bacterial infections
    3
    4
        Viral infections
    14
    20
        Fungal infections
    3
    0
    No statistical analyses for this end point

    Secondary: Triglyceride levels at Month 1, 3, 6, 9, 12

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    End point title
    		 Triglyceride levels at Month 1, 3, 6, 9, 12
    End point description
    Triglyceride levels at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mmol/L
    arithmetic mean (standard deviation)
        Month 1 (n=66, 60)
    2.6 ( 1.4 )
    2.0 ( 0.9 )
        Month 3 (n=65, 60)
    2.7 ( 1.3 )
    2.1 ( 1.0 )
        Month 6 (n=60, 60)
    2.6 ( 1.2 )
    2.0 ( 1.1 )
        Month 9 (n=55, 59)
    2.7 ( 1.3 )
    2.0 ( 1.0 )
        Month 12 (n=63, 60)
    2.7 ( 1.5 )
    2.1 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Total Cholesterol levels at Month 1, 3, 6, 9, 12

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    End point title
    		 Total Cholesterol levels at Month 1, 3, 6, 9, 12
    End point description
    Total Cholesterol levels at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mmol/L
    arithmetic mean (standard deviation)
        Month 1 (n=64, 60)
    0.8 ( 0.8 )
    -0.2 ( 0.7 )
        Month 3 (n=63, 60)
    1.0 ( 0.8 )
    -0.1 ( 0.9 )
        Month 6 (n=59, 60)
    1.1 ( 0.9 )
    -0.2 ( 0.8 )
        Month 9 (n=54, 59)
    1.1 ( 0.9 )
    -0.1 ( 0.9 )
        Month 12 (n=61, 60)
    0.8 ( 1.1 )
    -0.1 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Low-Density Lipoprotein (LDL)Cholesterol levels at Month 1, 3, 6, 9, 12

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    End point title
    		 Low-Density Lipoprotein (LDL)Cholesterol levels at Month 1, 3, 6, 9, 12
    End point description
    LDL Cholesterol levels at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mmol/L
    arithmetic mean (standard deviation)
        Month 1 (n=63, 57)
    0.4 ( 0.8 )
    0.0 ( 0.5 )
        Month 3 (n=62, 58)
    0.6 ( 0.7 )
    -0.0 ( 0.6 )
        Month 6 (n=58, 57)
    0.7 ( 0.8 )
    -0.0 ( 0.6 )
        Month 9 (n=53, 56)
    0.8 ( 0.8 )
    0.1 ( 0.7 )
        Month 12 (n=57, 57)
    0.5 ( 0.9 )
    0.1 ( 0.6 )
    No statistical analyses for this end point

    Secondary: High-Density Lipoprotein (HDL)Cholesterol levels at Month 1, 3, 6, 9, 12

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    End point title
    		 High-Density Lipoprotein (HDL)Cholesterol levels at Month 1, 3, 6, 9, 12
    End point description
    HDL Cholesterol levels at Month 1, 3, 6, 9, 12
    End point type
    Secondary
    End point timeframe
    Month 1, 3, 6, 9, 12
    End point values
    		 Quadruple low level IS regimen Centre specific triple IS regimen
    Number of subjects analysed
    67
    63
    Units: mmol/L
    arithmetic mean (standard deviation)
        Month 1 (n=65, 59)
    0.1 ( 0.3 )
    -0.1 ( 0.3 )
        Month 3 (n=64, 59)
    0.1 ( 0.3 )
    -0.0 ( 0.4 )
        Month 6 (n=60, 59)
    0.1 ( 0.4 )
    -0.0 ( 0.4 )
        Month 9 (n=55, 58)
    0.0 ( 0.4 )
    -0.0 ( 0.4 )
        Month 12 (n=59, 59)
    0.0 ( 0.5 )
    -0.0 ( 0.4 )
    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 reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Center specific triple IS
    Reporting group description
    		 Center specific triple IS

    Reporting group title
    Quadruple low level IS
    Reporting group description
    		 Quadruple low level IS

    Serious adverse events
    		 Center specific triple IS Quadruple low level IS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 63 (34.92%)
    29 / 67 (43.28%)
         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)
    BLADDER TRANSITIONAL CELL CARCINOMA
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHOCELE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHORRHOEA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL VENOUS DISEASE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    ABORTION SPONTANEOUS
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHILLS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERNIA
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLAMMATION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOCAL SWELLING
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOCALISED OEDEMA
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         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 / 63 (0.00%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL SWELLING
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    3 / 63 (4.76%)
    4 / 67 (5.97%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    LUNG TRANSPLANT REJECTION
         subjects affected / exposed
    0 / 63 (0.00%)
    5 / 67 (7.46%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BENIGN PROSTATIC HYPERPLASIA
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    BRONCHOSTENOSIS
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPISTAXIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOPTYSIS
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IDIOPATHIC PULMONARY FIBROSIS
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG DISORDER
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFILTRATION
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OBLITERATIVE BRONCHIOLITIS
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORGANISING PNEUMONIA
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAINFUL RESPIRATION
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SLEEP APNOEA SYNDROME
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FORCED EXPIRATORY VOLUME DECREASED
         subjects affected / exposed
    5 / 63 (7.94%)
    9 / 67 (13.43%)
         occurrences causally related to treatment / all
    4 / 8
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMMUNOSUPPRESSANT DRUG LEVEL INCREASED
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY FUNCTION TEST DECREASED
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         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
    COMPLICATIONS OF TRANSPLANTED LUNG
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MATERNAL EXPOSURE DURING PREGNANCY
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PELVIC FRACTURE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         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
    HYDROCELE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE CORONARY SYNDROME
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COR PULMONALE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIGHT VENTRICULAR FAILURE
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUS TACHYCARDIA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARAPARESIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCIATICA
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TREMOR
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         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
    LEUKOPENIA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    RETINAL DETACHMENT
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINAL VEIN OCCLUSION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DUODENAL ULCER HAEMORRHAGE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC ULCER
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGIC EROSIVE GASTRITIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    NIGHT SWEATS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URGE INCONTINENCE
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    PSEUDARTHROSIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ATYPICAL PNEUMONIA
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS BACTERIAL
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS VIRAL
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYTOMEGALOVIRUS INFECTION
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL INFECTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    2 / 63 (3.17%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    1 / 2
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFECTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    3 / 63 (4.76%)
    3 / 67 (4.48%)
         occurrences causally related to treatment / all
    0 / 3
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA VIRAL
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (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
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY SYNCYTIAL VIRUS INFECTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPERINFECTION BACTERIAL
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRACHEOBRONCHITIS
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 67 (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
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 67 (1.49%)
         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 / 63 (1.59%)
    0 / 67 (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: 5%
    Non-serious adverse events
    		 Center specific triple IS Quadruple low level IS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 63 (92.06%)
    62 / 67 (92.54%)
    Investigations
    BRONCHOALVEOLAR LAVAGE ABNORMAL
         subjects affected / exposed
    6 / 63 (9.52%)
    3 / 67 (4.48%)
         occurrences all number
    6
    3
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 67 (2.99%)
         occurrences all number
    4
    3
    FORCED EXPIRATORY VOLUME DECREASED
         subjects affected / exposed
    8 / 63 (12.70%)
    7 / 67 (10.45%)
         occurrences all number
    8
    7
    PULMONARY FUNCTION TEST DECREASED
         subjects affected / exposed
    3 / 63 (4.76%)
    6 / 67 (8.96%)
         occurrences all number
    4
    7
    Injury, poisoning and procedural complications
    COMPLICATIONS OF TRANSPLANTED LUNG
         subjects affected / exposed
    4 / 63 (6.35%)
    0 / 67 (0.00%)
         occurrences all number
    4
    0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    4 / 63 (6.35%)
    7 / 67 (10.45%)
         occurrences all number
    4
    7
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    9 / 63 (14.29%)
    8 / 67 (11.94%)
         occurrences all number
    11
    8
    MIGRAINE
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 67 (4.48%)
         occurrences all number
    7
    4
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    3 / 63 (4.76%)
    6 / 67 (8.96%)
         occurrences all number
    3
    6
    LEUKOPENIA
         subjects affected / exposed
    19 / 63 (30.16%)
    15 / 67 (22.39%)
         occurrences all number
    25
    18
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    5 / 63 (7.94%)
    2 / 67 (2.99%)
         occurrences all number
    5
    2
    OEDEMA PERIPHERAL
         subjects affected / exposed
    10 / 63 (15.87%)
    19 / 67 (28.36%)
         occurrences all number
    11
    20
    PYREXIA
         subjects affected / exposed
    5 / 63 (7.94%)
    1 / 67 (1.49%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    10 / 63 (15.87%)
    9 / 67 (13.43%)
         occurrences all number
    12
    10
    NAUSEA
         subjects affected / exposed
    10 / 63 (15.87%)
    9 / 67 (13.43%)
         occurrences all number
    14
    10
    VOMITING
         subjects affected / exposed
    4 / 63 (6.35%)
    5 / 67 (7.46%)
         occurrences all number
    8
    5
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    7 / 63 (11.11%)
    10 / 67 (14.93%)
         occurrences all number
    7
    11
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 67 (5.97%)
         occurrences all number
    4
    4
    PRODUCTIVE COUGH
         subjects affected / exposed
    5 / 63 (7.94%)
    1 / 67 (1.49%)
         occurrences all number
    5
    1
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    1 / 63 (1.59%)
    12 / 67 (17.91%)
         occurrences all number
    1
    14
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    5 / 63 (7.94%)
    2 / 67 (2.99%)
         occurrences all number
    5
    2
    BACK PAIN
         subjects affected / exposed
    5 / 63 (7.94%)
    2 / 67 (2.99%)
         occurrences all number
    5
    3
    PAIN IN EXTREMITY
         subjects affected / exposed
    5 / 63 (7.94%)
    8 / 67 (11.94%)
         occurrences all number
    5
    8
    Infections and infestations
    CYTOMEGALOVIRUS INFECTION
         subjects affected / exposed
    11 / 63 (17.46%)
    10 / 67 (14.93%)
         occurrences all number
    16
    14
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 67 (2.99%)
         occurrences all number
    5
    2
    NASOPHARYNGITIS
         subjects affected / exposed
    17 / 63 (26.98%)
    17 / 67 (25.37%)
         occurrences all number
    21
    20
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    7 / 63 (11.11%)
    8 / 67 (11.94%)
         occurrences all number
    10
    10
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 67 (5.97%)
         occurrences all number
    3
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Nov 2011
    Amendment 1: (prior to study start), introduced the following change: Clarification of the involvement of a CRO.
    01 Aug 2012
    Amendment 2: introduced the following changes: 1) Clarified that 1 measurement of the GFR by CKD EPI prior to screening and baseline visit was sufficient, rather than 2 measurements. 2) Tablets for preparation of a suspension, containing 0.1 mg everolimus, were allowed as study medication. 3) 1 spirometry assessment could be skipped at either screening or baseline visit when the visits occurred within 5 days of each other.
    30 Jan 2015
    Amendment 3: introduced the following changes: 1) Out of 3 scheduled GFR measurements (CKD-EPI), i.e. 1 prior screening (d-42 to d-1 before screening) 1 at screening (d -42 to d-1) and 1 at baseline (d1), all of these 3 measurements needed to be ≥ 40 mL/min and ≤ 100 mL/min/1.73 m2; however, 1 measurement out of these 3 with at least ≥ 50 mL/min/1.73 m2 and ≤ 90 mL/min/1.73m2 was sufficient to qualify for eligibility with respect to this criterion 2) Allowance of CsA trough level reduction once patients reached 2 years post-transplant 3) Trade names of ‘other immunosuppressive drugs’ were changed to generic names 4) Corrections of typos for clarification.
    25 Nov 2015
    Amendment 4: introduced the following change: Enrollment was to be terminated by 31-Dec-2015 due to slow recruitment.

    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
    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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