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    Clinical Trial Results:
    Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Paediatric Solid Organ Transplant Recipients

    Summary
    EudraCT number
    		 2004-000231-29
    Trial protocol
    		 ES   GB  
    Global end of trial date
    13 May 2005

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Nov 2016
    First version publication date
    30 Jun 2016
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Update to record for alignment with CTg

    Trial information

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    Trial identification
    Sponsor protocol code
    WV16726
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00090766
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Nov 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To describe the safety and tolerability profile of valganciclovir powder for oral solution and tablets in pediatric solid organ transplant recipients 2. To determine the pharmacokinetics of ganciclovir following oral administration of valganciclovir powder for oral solution and tablets in pediatric solid organ transplant recipients 3. To describe the incidence of cytomegalovirus (CMV) disease
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the declaration of Helsinki and the ICH E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all participants and/or their legally authorized representative. Participants signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug. Also, the independent Data Safety Monitoring Board ensured that participants were not put at undue risk.
    Background therapy
    		 NA
    Evidence for comparator
    		 Non-comparator study
    Actual start date of recruitment
    28 May 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 18
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Spain: 12
    Worldwide total number of subjects
    63
    EEA total number of subjects
    21
    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)
    13
    Children (2-11 years)
    25
    Adolescents (12-17 years)
    25
    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
    		 A total of 63 participants were enrolled in this study conducted from 28 May 2004 to 13 May 2005. The study was conducted at 18 centers in 7 countries.

    Pre-assignment
    Screening details
    		 Participants were screened within 48 hours prior to transplant surgery (Day 1) and received valganciclovir from Day 1.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Valganciclovir age group <= 2 years
    Arm description
    		 Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valganciclovir
    Investigational medicinal product code
    RO 107 9070
    Other name
    Valcyte
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valganciclovir powder was reconstituted with 91 millilitre (mL) of water to give a concentration of 50 mg/mL. Valganciclovir was also administered as a 450 mg film coated tablet if the projected dose was between 400 mg and 500 mg. If the projected dose was greater than 800 mg, two 450 mg tablets were taken. Valganciclovir powder for oral solution and/or tablets was administered to all the participants throughout 100 days dosing period.

    Arm title
    		 Valganciclovir age group >2 to < 12 years
    Arm description
    		 Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valganciclovir
    Investigational medicinal product code
    RO 107 9070
    Other name
    Valcyte
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valganciclovir powder was reconstituted with 91 mL of water to give a concentration of 50 mg/mL. Valganciclovir was also administered as a 450 mg film coated tablet if the projected dose was between 400 mg and 500 mg. If the projected dose was greater than 800 mg, two 450 mg tablets were taken. Valganciclovir powder for oral solution and/or tablets was administered to all the participants throughout 100 days dosing period.

    Arm title
    		 Valganciclovir age group >= 12 years
    Arm description
    		 Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valganciclovir
    Investigational medicinal product code
    RO 107 9070
    Other name
    Valcyte
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Valganciclovir powder was reconstituted with 91 mL of water to give a concentration of 50 mg/mL. Valganciclovir was also administered as a 450 mg film coated tablet if the projected dose was between 400 mg and 500 mg. If the projected dose was greater than 800 mg, two 450 mg tablets were taken. Valganciclovir powder for oral solution and/or tablets was administered to all the participants throughout 100 days dosing period.

    Number of subjects in period 1
    		Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Started
    17
    21
    25
    Completed
    14
    19
    22
    Not completed
    3
    2
    3
         Nephrectomy Planned
    -
    -
    1
         Death
    1
    -
    -
         Admin
    -
    2
    -
         Lost to follow-up
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Valganciclovir age group <= 2 years
    Reporting group description
    		 Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).

    Reporting group title
    Valganciclovir age group >2 to < 12 years
    Reporting group description
    		 Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).

    Reporting group title
    Valganciclovir age group >= 12 years
    Reporting group description
    		 Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).

    Reporting group values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years Total
    Number of subjects
    		 17 21 25 63
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0.6 ( 0.86 ) 6.9 ( 3.15 ) 14.2 ( 1.54 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 7 13 29
        Male
    		 8 14 12 34

    End points

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    End points reporting groups
    Reporting group title
    Valganciclovir age group <= 2 years
    Reporting group description
    		 Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).

    Reporting group title
    Valganciclovir age group >2 to < 12 years
    Reporting group description
    		 Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).

    Reporting group title
    Valganciclovir age group >= 12 years
    Reporting group description
    		 Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who received at least one dose of valganciclovir were included in the safety analysis.

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.

    Subject analysis set title
    PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The population PK analysis comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken.

    Primary: Number of Participants with Adverse Events Leading to Dose Interruption or Modification

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    End point title
    		 Number of Participants with Adverse Events Leading to Dose Interruption or Modification [1]
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported. Safety population was used for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed for this outcome measure
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Participants
    4
    2
    3
    No statistical analyses for this end point

    Primary: Number of Participants with Opportunistic Infections

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    End point title
    		 Number of Participants with Opportunistic Infections [2]
    End point description
    Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported. Safety population was used for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    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: No statistical analysis was performed for this outcome measure
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Participants
        Oral Candidiasis
    2
    0
    0
        Candidiasis
    1
    0
    0
        Herpes Simplex
    0
    1
    0
        Cytomegalovirus Antigen Positive
    1
    0
    0
        Cytomegalovirus Test Positive
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Any Adverse Events and Any Serious Adverse Events

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    End point title
    		 Number of Participants with Any Adverse Events and Any Serious Adverse Events [3]
    End point description
    An AE was defined as any untoward medical occurrence in a participantor clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above. Safety population was used for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    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: No statistical analysis was performed for this outcome measure
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Participants
        Any AE
    17
    18
    24
        Any SAE
    13
    11
    11
    No statistical analyses for this end point

    Primary: Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir

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    End point title
    		 Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir [4]
    End point description
    Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to,measure the plasma concentrations of valganciclovir. The PK analysis population was used for the analysis. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
    End point type
    Primary
    End point timeframe
    Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; and at Week 6, Week 10 and, Week 14
    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: No statistical analysis was performed for this outcome measure
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    20
    25
    Units: mcg*hr/mL
    arithmetic mean (standard deviation)
        In kidney recipients, n=2, 12, 19
    65.2 ( 16.6 )
    55 ( 11.9 )
    50 ( 11.6 )
        In liver recipients, n=9, 6, 2
    69.4 ( 35.4 )
    58.4 ( 6.18 )
    35.6 ( 2.76 )
        In heart recipients, n=6, 2, 4
    56.3 ( 23.2 )
    60 ( 19.3 )
    61.2 ( 26 )
    No statistical analyses for this end point

    Primary: Number of Participants with Adverse Events Leading to Discontinuation of the Study Drug

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    End point title
    		 Number of Participants with Adverse Events Leading to Discontinuation of the Study Drug [5]
    End point description
    An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported. Safety population was used for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    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: No statistical analysis was performed for this outcome measure.
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Participants
    1
    2
    0
    No statistical analyses for this end point

    Primary: Number of Participants with 3 Grade Shift from Baseline of Adverse Events in Haematology and Serum Chemistry

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    End point title
    		 Number of Participants with 3 Grade Shift from Baseline of Adverse Events in Haematology and Serum Chemistry [6]
    End point description
    The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. Safety population included all participants who received at least one dose of valganciclovir. The data was analyzed for overall study only. Safety population was used for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    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: No statistical analysis was performed for this outcome measure
    End point values
    		 Safety population
    Number of subjects analysed
    63
    Units: Participants
        Hemoglobin low, n= 63
    6
        White Blood Cell low, n=59
    3
        Lymphocytes low, n= 54
    3
        Neutrophils low, n= 54
    7
        Potassium low, n=56
    4
        Potassium high, n=57
    4
        Alkaline Phosphatase high, n=40
    1
        Alanine transaminase high, n=48
    1
        Total Bilirubin high, n=38
    1
        Sodium low, n=58
    2
        Sodium high, n=57
    0
        Calcium low, n=46
    1
        Phosphate low, n=43
    2
        Fasting Glucose low, n=39
    1
        Uric Acid high, n=21
    2
    No statistical analyses for this end point

    Primary: Number of Participants with 4 Grade Shift from Baseline of Adverse Events in Haematology and Serum Chemistry

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    End point title
    		 Number of Participants with 4 Grade Shift from Baseline of Adverse Events in Haematology and Serum Chemistry [7]
    End point description
    The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only. Safety population was used for the analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    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: No statistical analysis was performed for this outcome measure
    End point values
    		 Safety population
    Number of subjects analysed
    63
    Units: Participants
        Hemoglobin low, n= 63
    0
        White Blood Cell low, n=59
    1
        Lymphocytes low, n= 54
    3
        Neutrophils low, n= 54
    4
        Potassium low, n=56
    0
        Potassium high, n=57
    2
        Alkaline Phosphatase high, n=40
    0
        Alanine transaminase high, n=48
    0
        Total Bilirubin high, n=38
    0
        Sodium low, n=58
    0
        Sodium high, n=57
    1
        Calcium low, n=46
    3
        Phosphate low, n=43
    0
        Fasting Glucose low, n=39
    0
        Uric Acid high, n=21
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with Cytomegalovirus Disease Over Time

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    End point title
    		 Number of Participants with Cytomegalovirus Disease Over Time
    End point description
    Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction. Safety population was used for the analysis.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Participants
    0
    2
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment Failures

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    End point title
    		 Number of Participants with Treatment Failures
    End point description
    Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (ie, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity. ITT population was used for the analysis.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Number of participants
    2
    2
    0
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced Graft Loss

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    End point title
    		 Number of Participants who Experienced Graft Loss
    End point description
    Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation. The Intent to treat (ITT) population was used for analysis.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Participants
        Acute Graft Rejection
    1
    0
    0
        Chronic Graft Rejection
    0
    0
    0
        Recurrence of Underlying Disease
    0
    0
    0
        Technical Complications
    0
    0
    1
        Primary Graft Non-Function
    0
    0
    0
        Other
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Mean Maximum Plasma Concentration of Valganciclovir Over Time

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    End point title
    		 Mean Maximum Plasma Concentration of Valganciclovir Over Time
    End point description
    Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analysed. The PK analysis population was used for the analysis. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
    End point type
    Secondary
    End point timeframe
    Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; and at Week 6, Week 10 and, Week 14
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    20
    25
    Units: mcg/mL
    arithmetic mean (standard deviation)
        In kidney recipients, n=2, 12, 19
    10 ( 0.04 )
    8.74 ( 2.49 )
    7.85 ( 2.1 )
        In liver recipients, n=9, 6, 2
    11.7 ( 3.59 )
    9.35 ( 2.33 )
    5.55 ( 1.34 )
        In heart recipients, n=6, 2, 4
    8.22 ( 2.44 )
    12.5 ( 1.02 )
    9.5 ( 3.34 )
    No statistical analyses for this end point

    Secondary: Mean Elimination Half-Life of Valganciclovir Over Time

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    End point title
    		 Mean Elimination Half-Life of Valganciclovir Over Time
    End point description
    The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. The PK analysis population was used for the analysis. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
    End point type
    Secondary
    End point timeframe
    Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, and at Week 10 and, Week 14
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    20
    25
    Units: hour
    arithmetic mean (standard deviation)
        In kidney recipients, n=2, 12, 19
    3.1 ( 0.59 )
    4.47 ( 1.37 )
    5.69 ( 1.06 )
        In liver recipients, n=9, 6, 2
    2.72 ( 1.32 )
    3.61 ( 0.8 )
    4.5 ( 0.25 )
        In heart recipients, n=6, 2, 4
    3.6 ( 1.73 )
    2.62 ( 0.65 )
    5.05 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Number of Participants Who Experienced Episodes of Rejection Over Time

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    End point title
    		 Number of Participants Who Experienced Episodes of Rejection Over Time
    End point description
    Participants with biopsy proven active rejection were reported. ITT population was used for the analysis.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    End point values
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Number of subjects analysed
    17
    21
    25
    Units: Participants
    5
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 26
    Adverse event reporting additional description
    Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Valganciclovir age group <= 2 years
    Reporting group description
    		 Participants aged <= 2 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].

    Reporting group title
    Valganciclovir age group >2 to < 12 years
    Reporting group description
    		 Participants aged >2 to < 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].

    Reporting group title
    Valganciclovir age group >= 12 years
    Reporting group description
    		 Participants aged >= 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].

    Serious adverse events
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 17 (76.47%)
    11 / 21 (52.38%)
    11 / 25 (44.00%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmablastic lymphoma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Gastrostomy tube insertion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    3 / 25 (12.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Cytomegalovirus test positive
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus antigen positive
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukoencephalopathy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intra−abdominal haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal hypomotility
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic artery thrombosis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic artery stenosis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus Viraemia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epstein−barr virus infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolic disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Valganciclovir age group <= 2 years Valganciclovir age group >2 to < 12 years Valganciclovir age group >= 12 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    17 / 21 (80.95%)
    21 / 25 (84.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 17 (23.53%)
    6 / 21 (28.57%)
    8 / 25 (32.00%)
         occurrences all number
    4
    6
    8
    Haematoma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 17 (29.41%)
    8 / 21 (38.10%)
    4 / 25 (16.00%)
         occurrences all number
    5
    9
    5
    Oedema Peripheral
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    5 / 25 (20.00%)
         occurrences all number
    0
    0
    5
    Irritability
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Catheter Site Discharge
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Catheter Site Inflammation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Liver Transplant Rejection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    0
    Transplant Rejection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    0
    Milk Allergy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 17 (5.88%)
    5 / 21 (23.81%)
    1 / 25 (4.00%)
         occurrences all number
    1
    7
    1
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    3 / 25 (12.00%)
         occurrences all number
    0
    1
    3
    Pleural Effusion
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    1 / 25 (4.00%)
         occurrences all number
    1
    2
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    0
    5
    Bronchospasm
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    0
    Atelectasis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Nasal Congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Wheezing
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Pneumothorax
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Stridor
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Anxiety
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences all number
    1
    1
    0
    Investigations
    Epstein-Barr Virus Test positive
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Blood Albumin Decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    White Blood Cell Count Increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Incision site infection
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    4 / 25 (16.00%)
         occurrences all number
    0
    2
    4
    Procedural pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    1 / 25 (4.00%)
         occurrences all number
    0
    2
    1
    Device Failure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Graft Ischaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Postoperative Thoracic procedure complications
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Pericardial Effusion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    2 / 25 (8.00%)
         occurrences all number
    0
    1
    2
    Bradycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac Disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Left Ventricular Failure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus Bradycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    0
    7
    Convulsion
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences all number
    2
    3
    0
    Dystonia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Encephalomalacia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 17 (52.94%)
    4 / 21 (19.05%)
    0 / 25 (0.00%)
         occurrences all number
    11
    4
    0
    Neutropenia
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 21 (4.76%)
    1 / 25 (4.00%)
         occurrences all number
    5
    1
    1
    Leukocytosis
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences all number
    3
    1
    0
    Leukopenia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Thrombocythaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Lymphopenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 17 (41.18%)
    8 / 21 (38.10%)
    6 / 25 (24.00%)
         occurrences all number
    7
    15
    7
    Vomiting
         subjects affected / exposed
    2 / 17 (11.76%)
    7 / 21 (33.33%)
    7 / 25 (28.00%)
         occurrences all number
    2
    8
    7
    Nausea
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    6 / 25 (24.00%)
         occurrences all number
    0
    2
    6
    Constipation
         subjects affected / exposed
    0 / 17 (0.00%)
    5 / 21 (23.81%)
    2 / 25 (8.00%)
         occurrences all number
    0
    5
    2
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 21 (14.29%)
    1 / 25 (4.00%)
         occurrences all number
    1
    3
    2
    Abdominal Distention
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    1 / 25 (4.00%)
         occurrences all number
    0
    2
    1
    Ascites
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    1
    2
    0
    Teething
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Biliary Tract Disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic Function Abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 21 (19.05%)
    1 / 25 (4.00%)
         occurrences all number
    1
    4
    1
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    2
    Acne
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    3 / 25 (12.00%)
         occurrences all number
    0
    1
    3
    Dermatitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Dermatitis Diaper
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Hirsutism
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Pruritus Generalised
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 17 (0.00%)
    4 / 21 (19.05%)
    0 / 25 (0.00%)
         occurrences all number
    0
    5
    0
    Dysuria
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    Acute Prerenal failure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Renal Failure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in Extremity
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    3 / 25 (12.00%)
         occurrences all number
    0
    1
    3
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 17 (23.53%)
    5 / 21 (23.81%)
    7 / 25 (28.00%)
         occurrences all number
    5
    8
    12
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    3 / 25 (12.00%)
         occurrences all number
    1
    1
    3
    Urinary Tract Infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 21 (4.76%)
    4 / 25 (16.00%)
         occurrences all number
    0
    1
    4
    Otitis Media
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    0
    2
    Cellulitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Clostridium Colitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    1
    Epstein-Barr Virus Infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Oral Candidiasis
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    0
    Sepsis
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    4
    0
    0
    Abdominal Infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Candidiasis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Central Line Infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Para Influenzae Virus Infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Stenotrophomonas infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 21 (19.05%)
    0 / 25 (0.00%)
         occurrences all number
    2
    4
    0
    Hyperkalaemia
         subjects affected / exposed
    3 / 17 (17.65%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    3
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 21 (9.52%)
    1 / 25 (4.00%)
         occurrences all number
    1
    2
    1
    Metabolic Acidosis
         subjects affected / exposed
    4 / 17 (23.53%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    5
    0
    0
    Hypokalaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences all number
    3
    1
    0
    Feeding disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 21 (4.76%)
    0 / 25 (0.00%)
         occurrences all number
    1
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 21 (9.52%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 21 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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

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