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    Clinical Trial Results:
    A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients

    Summary
    EudraCT number
    		 2009-012259-21
    Trial protocol
    		 ES   GB   DE   BE   FR  
    Global end of trial date
    02 Apr 2017

    Results information
    Results version number
    		 v3(current)
    This version publication date
    29 Jul 2018
    First version publication date
    28 Mar 2018
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    Results updated for consistency

    Trial information

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    Trial identification
    Sponsor protocol code
    F506-CL-0404
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01371344
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Acronym: PROGRESSION
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe, Ltd
    Sponsor organisation address
    2000 Hillswood Drive, Chertsey, United Kingdom, KT16 0RS
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe, Ltd, Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe, Ltd, Astellas.resultsdisclosure@astellas.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The study had 2 parts: Part A (F506-CL-0404A) and Part B (F506-CL-0404B). The objective of F506-CL-0404A was to monitor the safety of and efficacy of Modigraf® (tacrolimus granules) in stable paediatric allograft recipients. The objective of F506-CL-0404B was to monitor dose changes and tacrolimus whole blood trough levels after conversion from a tacrolimus granules based immunosuppression regimen to a Prograf® (tacrolimus capsules) based immunosuppression regimen. Part A was completed as planned, however the study was terminated during Part B due to low enrollment in Part B.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jun 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    United Kingdom: 9
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    17
    Children (2-11 years)
    29
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Children aged ≤ 12 years were enrolled at 11 sites in a total of 6 countries: UK (2 sites), Spain (3 sites), Germany (2 sites), Belgium (1 site), Poland (1 site) and France (2 sites).

    Pre-assignment
    Screening details
    		 Pediatric participants who had undergone liver, kidney or heart transplantation and who had previously participated F506-CL-0403 study were enrolled in Part A of this study. Participants who participated in Part A or F506-CL-0403 and who were converted to receive tacrolimus capsules were enrolled in Part B.

    Period 1
    Period 1 title
    Part A
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Heart Transplant (Tacrolimus granules)
    Arm description
    		 In Part A of the study, participants who were heart transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus granules
    Investigational medicinal product code
    FK506
    Other name
    Modigraf®
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the same dose regimen of tacrolimus granules as they were receiving at the end of the F506-CL-0403 study, and the first dose was administered on day 1. Subsequent oral tacrolimus doses were adjusted by the investigator based on clinical evidence of efficacy and occurrence of adverse events and observing the recommended whole blood trough level range of 5 to 20 ng/ml. The tacrolimus granules for oral suspension were available in sachets containing either 0.2 mg or 1 mg tacrolimus granules per sachet.

    Arm title
    		 Part A: Liver Transplant (Tacrolimus granules)
    Arm description
    		 In Part A of the study, participants who were liver transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus granules
    Investigational medicinal product code
    FK506
    Other name
    Modigraf®
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the same dose regimen of tacrolimus granules as they were receiving at the end of the F506-CL-0403 study, and the first dose was administered on day 1. Subsequent oral tacrolimus doses were adjusted by the investigator based on clinical evidence of efficacy and occurrence of adverse events and observing the recommended whole blood trough level range of 5 to 20 ng/ml. The tacrolimus granules for oral suspension were available in sachets containing either 0.2 mg or 1 mg tacrolimus granules per sachet.

    Arm title
    		 Part A: Kidney Transplant (Tacrolimus granules)
    Arm description
    		 In Part A of the study, participants who were kidney transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus granules
    Investigational medicinal product code
    FK506
    Other name
    Modigraf®
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received the same dose regimen of tacrolimus granules as they were receiving at the end of the F506-CL-0403 study, and the first dose was administered on day 1. Subsequent oral tacrolimus doses were adjusted by the investigator based on clinical evidence of efficacy and occurrence of adverse events and observing the recommended whole blood trough level range of 5 to 20 ng/ml. The tacrolimus granules for oral suspension were available in sachets containing either 0.2 mg or 1 mg tacrolimus granules per sachet.

    Number of subjects in period 1
    		Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Started
    17
    18
    12
    Completed
    16
    11
    10
    Not completed
    1
    7
    2
         Intolerable Adverse Event
    -
    1
    1
         Withdrawal of Consent
    -
    3
    1
         Other
    -
    1
    -
         Lost to follow-up
    1
    -
    -
         Retransplantation
    -
    2
    -
    Period 2
    Period 2 title
    Part B
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Part B: All Participants (Tacrolimus capsules)
    Arm description
    		 In Part B of the study, participants who were heart, kidney or liver transplant recipients and who were converted from tacrolimus granules-based immunosuppression regimen, received tacrolimus capsules twice daily for 1 month and thereafter received commercially available tacrolimus capsules.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus capsules
    Investigational medicinal product code
    FK506
    Other name
    Prograf®
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received an initial daily dose of tacrolimus capsules that is identical to the daily dose of tacrolimus granules prior to conversion to tacrolimus capsules and was administered on day 1. Subsequent oral tacrolimus doses were adjusted based on clinical evidence of efficacy and occurrence of adverse events, and observed the recommended whole blood trough level range of 5 to 20 ng/ml. Tacrolimus capsules contained 0.5 mg, 1 mg or 5 mg of tacrolimus per capsule.

    Number of subjects in period 2 [1]
    		Part B: All Participants (Tacrolimus capsules)
    Started
    5
    Completed
    6
    Joined
    1
         Joined from F506-CL-0403
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Part A and Part B are independent of each other, where: (1) Participants can be enrolled in Part A only, and may not be enrolled in Part B; (2) Participants can be can be enrolled in Part A and subsequently to Part B; or (3) Participants can directly be enrolled into Part B only.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: Heart Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were heart transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group title
    Part A: Liver Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were liver transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group title
    Part A: Kidney Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were kidney transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules) Total
    Number of subjects
    		 17 18 12
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.3 ( 4.1 ) 2.3 ( 2.8 ) 5.4 ( 3.0 ) -
    Gender categorical
    Units:
        Male
    		 13 10 9 32
        Female
    		 4 8 3 15
    Race
    Units: Subjects
        White
    		 17 18 11 46
        Black or African American
    		 0 0 0 0
        Asian
    		 0 0 1 1
        Other
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Part A: Heart Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were heart transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group title
    Part A: Liver Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were liver transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group title
    Part A: Kidney Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were kidney transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.
    Reporting group title
    Part B: All Participants (Tacrolimus capsules)
    Reporting group description
    		 In Part B of the study, participants who were heart, kidney or liver transplant recipients and who were converted from tacrolimus granules-based immunosuppression regimen, received tacrolimus capsules twice daily for 1 month and thereafter received commercially available tacrolimus capsules.

    Primary: Part A: Number of Participants with Acute Rejection Episodes

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    End point title
    		 Part A: Number of Participants with Acute Rejection Episodes [1]
    End point description
    Rejection episodes/acute rejections were indicated by clinical and/or laboratory signs, and were classified according to their rejection specific treatment: •Spontaneously Resolving Acute Rejection: not treated with new or increased corticosteroid medication, antibodies or any other medication and resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Sensitive Acute Rejection: treated with new or increased corticosteroid medication only and which has resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Resistant Acute Rejection: did not resolve following treatment with corticosteroids; - Resolved with further treatment: any acute rejection with an end date AND a treatment other than corticosteroid used; - Unresolved with further treatment: any acute rejection with no end date AND a treatment other than corticosteroid used; - Unresolved with no further treatment: any acute rejection with no end date AND ONLY corticosteroid treatment was used. SAF.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part A of the study.
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    12
    Units: Participants
        Spontaneously Resolving Acute Rejection
    1
    0
    0
        Corticosteroid Sensitive Acute Rejection
    3
    2
    0
        Corticosteroid Resistant Acute Rejections
    0
    1
    0
        Other Acute Rejections
    1
    0
    1
    No statistical analyses for this end point

    Primary: Part A: Severity of BPARs

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    End point title
    		 Part A: Severity of BPARs [2]
    End point description
    The severity of BPARs was categorized with specific criteria by organ: For kidney transplant participants, according to Banff ‘97 Diagnostic categories for renal allograft biopsies – Banff ’07 update (C4d deposition, Acute antibody-mediated rejection I, II, and III, Acute T cell mediated rejection IA, IB, IIA, IIB and III); for liver transplant participants, according to 1997 Banff Schema for Grading of Liver Allograft Rejection - Rejection Activity Index score (sum of grades: 1-mild, 2-moderate, 3-severe; range from 0-9); for heart, according to Standardized Nomenclature of the International Society of Heart and Lung Transplantation - Standardised Cardiac Biopsy Grading: Acute Cellular Rejection 2004 (mild, moderate, severe). The analysis population was the Safety Analysis Set (SAF), which consisted of participants took at least 1 dose of study drug. Categories not applicable to the reporting groups are denoted as "99999."
    End point type
    Primary
    End point timeframe
    Up to 12 months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part A of the study.
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    12
    Units: Participants
        Heart: Mild
    2
    99999
    99999
        Heart: Moderate
    0
    99999
    99999
        Heart: Severe
    0
    99999
    99999
        Liver RAI Score 0-2
    99999
    0
    99999
        Liver RAI Score 3
    99999
    0
    99999
        Liver RAI Score 4-5
    99999
    0
    99999
        Liver RAI Score 6-7
    99999
    2
    99999
        Liver RAI Score 8-9
    99999
    1
    99999
        Kidney: C4d deposition
    99999
    99999
    0
        Kidney: Acute antibody-mediated rejection I
    99999
    99999
    0
        Kidney: Acute antibody-mediated rejection II
    99999
    99999
    0
        Kidney: Acute antibody-mediated rejection III
    99999
    99999
    0
        Kidney: T-cell mediated rejection IA
    99999
    99999
    0
        Kidney: T-cell mediated rejection IB
    99999
    99999
    0
        Kidney: T-cell mediated rejection IIA
    99999
    99999
    0
        Kidney: T-cell mediated rejection IIB
    99999
    99999
    0
        Kidney: T-cell mediated rejection III
    99999
    99999
    0
    No statistical analyses for this end point

    Primary: Part A: Patient Survival

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    End point title
    		 Part A: Patient Survival [3]
    End point description
    Patient survival was reported as the number of deaths that occurred during Part A of the study. The analysis population was the SAF.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part A of the study.
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    12
    Units: Participants
        Deaths
    0
    0
    0
    No statistical analyses for this end point

    Primary: Part A: Graft Survival

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    End point title
    		 Part A: Graft Survival [4]
    End point description
    Graft survival was reported as the number of participants who experienced graft loss. Graft loss was defined as retransplantation or death or return to pretransplantation treatment modality for 6 weeks or longer. Additionally, kidney transplanted participants with ongoing dialysis at the end of study were counted as participants with graft loss. The analysis population was the SAF.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part A of the study.
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    12
    Units: Participants
        Graft losses
    0
    2
    0
    No statistical analyses for this end point

    Primary: Part A: Number of Participants with Adverse Events (AEs)

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    End point title
    		 Part A: Number of Participants with Adverse Events (AEs) [5]
    End point description
    Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. clinical laboratory tests, vital signs, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. A treatment emergent adverse event (TEAE) was defined as an AE observed after investigational drug administration. The analysis population was the SAF.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to 30 days after last dose of study drug (up to 13 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part A of the study.
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    12
    Units: Participants
        Any TEAE
    16
    15
    12
        Drug-related TEAEs
    9
    12
    11
        Deaths
    0
    0
    0
        Serious TEAEs
    8
    9
    9
        Drug-related Serious TEAEs
    3
    2
    7
        Deaths Resulting from AEs
    0
    0
    0
        TEAEs Leading to Discontinuation of Study Drug
    0
    1
    2
        Drug-related TEAEs Leading to Disc. of Study Drug
    0
    1
    2
    No statistical analyses for this end point

    Primary: Part A: Tacrolimus Mean Trough Levels

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    End point title
    		 Part A: Tacrolimus Mean Trough Levels [6]
    End point description
    The analysis population was the SAF. N indicates the number of participants with available data. Due to participants discontinuing the study drug at certain time points, data were not calculated and denoted as "99999."
    End point type
    Primary
    End point timeframe
    Day 1, Months 1, 2, 3, 6, 9, 12 (prior to each study drug dosing)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part A of the study.
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    12
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1 [N=8, 15, 9]
    8.76 ( 2.38 )
    11.68 ( 4.60 )
    11.71 ( 3.64 )
        Month 1 [N=17, 18, 11]
    11.74 ( 5.07 )
    9.80 ( 3.34 )
    7.11 ( 2.41 )
        Month 2 [N=16, 12, 11]
    9.80 ( 4.01 )
    9.15 ( 2.28 )
    5.65 ( 1.58 )
        Month 3 [N=15, 11, 11]
    9.29 ( 3.17 )
    12.82 ( 11.97 )
    6.50 ( 1.97 )
        Month 6 [N=1, 1, 7]
    5.30 ( 99999 )
    19.20 ( 99999 )
    7.37 ( 5.09 )
        Month 9 [N=1, 0, 6]
    3.40 ( 99999 )
    99999 ( 99999 )
    5.12 ( 0.99 )
        Month 12 [N=0, 0, 6]
    99999 ( 99999 )
    99999 ( 99999 )
    4.95 ( 0.65 )
        Last Day on Study Drug [17, 18, 11]
    8.30 ( 2.13 )
    11.73 ( 9.77 )
    5.13 ( 1.71 )
    No statistical analyses for this end point

    Primary: Part A: Number of Dose Adjustments

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    End point title
    		 Part A: Number of Dose Adjustments [7]
    End point description
    Study drug doses were adjusted based on clinical evidence of efficacy and occurrence of adverse events, and taking into consideration the recommended whole blood trough level range of 5-20 ng/ml. The analysis population was the SAF. N indicates the number of participants with available data. Due to participants discontinuing the study drug at certain time points, data were not calculated and are denoted as "99999."
    End point type
    Primary
    End point timeframe
    Months 1, 2, 3, 6, 9, 12
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part A of the study.
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    10
    Units: dose adjustments
    arithmetic mean (standard deviation)
        Month 1 [N=17, 18, 8]
    7.6 ( 5.3 )
    12.1 ( 8.5 )
    4.3 ( 3.3 )
        Month 2 [N=10, 9, 5]
    2.2 ( 1.4 )
    5.8 ( 4.3 )
    3.8 ( 5.7 )
        Month 3 [N=1, 5, 6]
    2.0 ( 99999 )
    3.2 ( 1.9 )
    1.2 ( 0.4 )
        Month 6 [N=1, 0, 4]
    2.0 ( 99999 )
    99999 ( 99999 )
    1.8 ( 1.0 )
        Month 9 [N=0, 0, 2]
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 0.0 )
        Month 12 [N=0, 0, 1]
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    No statistical analyses for this end point

    Primary: Part B: Number of Participants with AEs

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    End point title
    		 Part B: Number of Participants with AEs [8]
    End point description
    Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. clinical laboratory tests, vital signs, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A SAE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. A TEAE was defined as an AE observed after investigational drug administration. The analysis population was the conversion analysis set was comprised of all participants enrolled in Part B who took at least 1 dose of study drug (tacrolimus capsules).
    End point type
    Primary
    End point timeframe
    From first dose of study drug (tacrolimus capsules) up to 7 days after last dose (up to 38 days)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part B of the study.
    End point values
    		 Part B: All Participants (Tacrolimus capsules)
    Number of subjects analysed
    6
    Units: participants
        Any TEAE
    4
        SAEs
    0
        Drug-related AEs
    1
    No statistical analyses for this end point

    Primary: Part B: Tacrolimus Trough Levels Prior to and After Conversion

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    End point title
    		 Part B: Tacrolimus Trough Levels Prior to and After Conversion [9]
    End point description
    The analysis population was the conversion analysis set. N indicates the number of participants with available data. Values prior to conversion were the last trough level prior to first dose of study drug (tacrolimus capsules). Values after conversion were the first trough level after first dose of study drug (tacrolimus capsules).
    End point type
    Primary
    End point timeframe
    Day -1 up to 1 month
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part B of the study.
    End point values
    		 Part B: All Participants (Tacrolimus capsules)
    Number of subjects analysed
    6
    Units: ng/mL
    median (full range (min-max))
        Prior to Conversion [N=4]
    5.20 (3.1 to 7.1)
        After to Conversion [N=6]
    5.55 (2.8 to 9.0)
    No statistical analyses for this end point

    Primary: Part B: Number of Dose Adjustments

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    End point title
    		 Part B: Number of Dose Adjustments [10]
    End point description
    The analysis population was the conversion analysis set. Only participants with dose adjustments were included in the analysis.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to 1 month
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this is a single-arm study, there were no pre-determined hypothetical or comparative statistical analyses performed in Part B of the study.
    End point values
    		 Part B: All Participants (Tacrolimus capsules)
    Number of subjects analysed
    3
    Units: participants
        1 adjustment
    1
        2 adjustments
    0
        3 adjustments
    2
    No statistical analyses for this end point

    Secondary: Part A: Number of Participants with Biopsy-proven Acute Rejection Episodes (BPARs)

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    End point title
    		 Part A: Number of Participants with Biopsy-proven Acute Rejection Episodes (BPARs)
    End point description
    BPAR episodes were defined as acute rejection episodes confirmed by biopsy, and were classified according to their rejection specific treatment: •Spontaneously Resolving Acute Rejection: not treated with new or increased corticosteroid medication, antibodies or any other medication and resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Sensitive Acute Rejection: treated with new or increased corticosteroid medication only and which has resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Resistant Acute Rejection: did not resolve following treatment with corticosteroids; - Resolved with further treatment: any acute rejection with an end date AND a treatment other than corticosteroid used; - Unresolved with further treatment: any acute rejection with no end date AND a treatment other than corticosteroid used; - Unresolved with no further treatment: any acute rejection with no end date AND ONLY corticosteroid treatment used. SAF.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules)
    Number of subjects analysed
    17
    18
    12
    Units: participants
    number (not applicable)
        Spontaneously Resolving Acute Rejection
    0
    0
    0
        Corticosteroid Sensitive Acute Rejection
    2
    2
    0
        Corticosteroid Resistant Acute Rejection
    0
    1
    0
        Other Acute Rejections
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part A: From first dose of study drug (tacrolimus granules) up to 30 days after last dose of study drug (up to 13 months); Part B: From first dose of study drug (tacrolimus capsules) up to 7 days after last dose (up to 38 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Part A: Heart Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were heart transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group title
    Part A: Liver Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were liver transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group title
    Part A: Kidney Transplant (Tacrolimus granules)
    Reporting group description
    		 In Part A of the study, participants who were kidney transplant recipients received tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant’s country.

    Reporting group title
    Part B: All Participants (Tacrolimus capsules)
    Reporting group description
    		 In Part B of the study, participants who were heart, kidney or liver transplant recipients and who were converted from tacrolimus granules-based immunosuppression regimen, received tacrolimus capsules twice daily for 1 month and thereafter received commercially available tacrolimus capsules.

    Serious adverse events
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules) Part B: All Participants (Tacrolimus capsules)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 17 (47.06%)
    9 / 18 (50.00%)
    9 / 12 (75.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Surgical and medical procedures
    Central venous catheter removal
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug interaction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Treatment noncompliance
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung consolidation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Body temperature increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Biliary anastomosis complication
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complications of transplanted liver
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac hypertrophy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neurotoxicity
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic vein thrombosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Oliguria
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 18 (5.56%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal protozoal infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    9 / 10
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: Heart Transplant (Tacrolimus granules) Part A: Liver Transplant (Tacrolimus granules) Part A: Kidney Transplant (Tacrolimus granules) Part B: All Participants (Tacrolimus capsules)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 17 (94.12%)
    15 / 18 (83.33%)
    11 / 12 (91.67%)
    2 / 6 (33.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 17 (29.41%)
    3 / 18 (16.67%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    5
    3
    2
    0
    Diastolic hypertension
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thrombosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Surgical and medical procedures
    Catheter removal
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Central venous catheter removal
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Device occlusion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Chills
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Generalised oedema
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 18 (16.67%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    4
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Reproductive system and breast disorders
    Genital pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
    7 / 12 (58.33%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    8
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pneumothorax
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    4 / 12 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting psychogenic
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Body temperature increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immunosuppressant drug level increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Complications of transplanted kidney
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Complications of transplanted liver
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Contusion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Radius fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pericardial effusion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Hypertonia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Tremor
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 18 (22.22%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    5
    2
    0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neutropenia
         subjects affected / exposed
    4 / 17 (23.53%)
    3 / 18 (16.67%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    4
    5
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    1
    Eye disorders
    Eye swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    4 / 17 (23.53%)
    3 / 18 (16.67%)
    7 / 12 (58.33%)
    1 / 6 (16.67%)
         occurrences all number
    4
    5
    13
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    8 / 18 (44.44%)
    6 / 12 (50.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    10
    13
    0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bile duct stenosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatotoxicity
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Alopecia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermatitis exfoliative
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Drug eruption
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal failure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nephropathy toxic
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal injury
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal impairment
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 18 (16.67%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Infections and infestations
    Biliary tract infection bacterial
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Biliary tract infection fungal
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Clostridial infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 18 (16.67%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Device related infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal candidiasis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Genital infection male
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Human herpesvirus 6 infection
         subjects affected / exposed
    0 / 17 (0.00%)
    6 / 18 (33.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    0
    0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    4 / 12 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    4
    2
    Oral candidiasis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Viral infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    4 / 17 (23.53%)
    6 / 18 (33.33%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    4
    6
    1
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 17 (0.00%)
    7 / 18 (38.89%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    8
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was terminated during Part B, due to low number of participants enrolled in Part B.
    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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