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    Clinical Trial Results:
    A Phase 2, Randomized, Dose-Ranging Study to Assess the Safety And Anti-Cytomegalovirus (CMV) Activity of Maribavir Versus Valganciclovir for Treatment of CMV Infections in Transplant Recipients Who Do Not Have CMV Organ Disease

    Summary
    EudraCT number
    2010-024247-32
    Trial protocol
    BE   DE   FR   AT   ES   GB  
    Global end of trial date
    25 Jul 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    25 Nov 2018
    First version publication date
    01 Jul 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Update statistical analysis for one endpoint.

    Trial information

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    Trial identification
    Sponsor protocol code
    1263-203
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shire Development LLC (formerly ViroPharma Incorporated)
    Sponsor organisation address
    725 Chesterbrook Boulevard, Wayne, Pennsylvania, United States, 19087
    Public contact
    Clinical Study Manager, Viropharma , 0032 23007811, Katrien.Danneels@viropharma.com
    Scientific contact
    Clinical Study Manager, Viropharma , 0032 23007811, Katrien.Danneels@viropharma.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
    11 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of different doses of maribavir versus valganciclovir, administered orally for up to 12 weeks, for treatment of Cytomegalovirus (CMV) infections in recipients of stem cell or solid organ transplants who do not have CMV organ disease.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Austria: 10
    Country: Number of subjects enrolled
    Belgium: 67
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 27
    Worldwide total number of subjects
    159
    EEA total number of subjects
    159
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    124
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects who had neither CMV organ disease nor CMV infection that was genotypically resistant to other anti-CMV drugs and documented CMV infection in blood or plasma, with a screening value of >= 1,000 to <= 100,000 DNA copies/mL as determined by quantitative polymerase chain reaction (PCR) or comparable quantitative CMV assay type were recruited.

    Pre-assignment
    Screening details
    Of the 174 subjects screened to participate in the study, 13 were screen failures. Therefore, 161 were randomized.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst, Carer, Monitor
    Blinding implementation details
    Regarding subjects who received maribavir; subjects, investigators, and study staff knew that they were receiving maribavir, but were blinded to dose strength and an unblinded, independent statistician from the Sponsor’s biostatistics contract research organization (CRO) provided the data monitoring committee (DMC) with unblinded data reports for their review.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Maribavir 400 mg
    Arm description
    Maribavir 400 milligrams (mg) tablet orally twice a day (BID) up to 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Maribavir
    Investigational medicinal product code
    VP 41263, SHP620
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maribavir 400 mg tablet orally BID up to 12 weeks.

    Arm title
    Maribavir 800 mg
    Arm description
    Maribavir 800 mg tablet orally BID up to 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Maribavir
    Investigational medicinal product code
    VP 41263, SHP620
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maribavir 800 mg tablet orally BID up to 12 weeks.

    Arm title
    Maribavir 1200 mg
    Arm description
    Maribavir 1200 mg tablet orally BID up to 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Maribavir
    Investigational medicinal product code
    VP 41263, SHP620
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maribavir 1200 mg tablet orally BID up to 12 weeks.

    Arm title
    Valganciclovir 900 mg
    Arm description
    Valganciclovir 900 mg tablet orally BID for 3 weeks, thereafter once daily (QD) up to 9 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Valganciclovir
    Investigational medicinal product code
    Other name
    Valcyte®, Roche
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Valganciclovir 900 mg tablet orally BID for 3 weeks, thereafter QD up to 9 weeks.

    Number of subjects in period 1
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Started
    40
    40
    39
    40
    Completed
    36
    36
    34
    34
    Not completed
    4
    4
    5
    6
         Death
    1
    1
    3
    3
         Physician decision
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    3
    2
    3
         Lost to follow-up
    2
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maribavir 400 mg
    Reporting group description
    Maribavir 400 milligrams (mg) tablet orally twice a day (BID) up to 12 weeks.

    Reporting group title
    Maribavir 800 mg
    Reporting group description
    Maribavir 800 mg tablet orally BID up to 12 weeks.

    Reporting group title
    Maribavir 1200 mg
    Reporting group description
    Maribavir 1200 mg tablet orally BID up to 12 weeks.

    Reporting group title
    Valganciclovir 900 mg
    Reporting group description
    Valganciclovir 900 mg tablet orally BID for 3 weeks, thereafter once daily (QD) up to 9 weeks.

    Reporting group values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg Total
    Number of subjects
    40 40 39 40 159
    Age categorical
    Units: Subjects
        18 to 44 years
    11 7 5 9 32
        45 to 64 years
    16 26 26 24 92
        65 to 75 years
    12 7 8 6 33
        greater than (>) 75 years
    1 0 0 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53 ± 14.18 54.4 ± 12.72 55.9 ± 10.69 54.5 ± 12.36 -
    Gender categorical
    Units: Subjects
        Female
    18 13 17 13 61
        Male
    22 27 22 27 98

    End points

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    End points reporting groups
    Reporting group title
    Maribavir 400 mg
    Reporting group description
    Maribavir 400 milligrams (mg) tablet orally twice a day (BID) up to 12 weeks.

    Reporting group title
    Maribavir 800 mg
    Reporting group description
    Maribavir 800 mg tablet orally BID up to 12 weeks.

    Reporting group title
    Maribavir 1200 mg
    Reporting group description
    Maribavir 1200 mg tablet orally BID up to 12 weeks.

    Reporting group title
    Valganciclovir 900 mg
    Reporting group description
    Valganciclovir 900 mg tablet orally BID for 3 weeks, thereafter once daily (QD) up to 9 weeks.

    Subject analysis set title
    Maribavir All Doses
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Maribavir (N= 119) 400 or 800 or 1200 mg tablet orally BID for 12 weeks.

    Primary: Number Of Subjects With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 3 Weeks

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    End point title
    Number Of Subjects With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 3 Weeks
    End point description
    Plasma CMV DNA was assayed using polymerase chain reaction (PCR) testing, this method was linear over the range 200-100,000 viral copies per milliliter (copies/mL) with a lower limit of quantification (LLOQ) of 200 copies/mL and any results below this LLOQ are referred to as undetectable. Confirmed undetectable plasma CMV DNA (central laboratory) was defined as 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days. Intent-to-treat Safety (ITT-S) Population included all subjects who were randomized and received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Within 3 Weeks
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg Maribavir All Doses
    Number of subjects analysed
    40
    40
    39
    40
    119
    Units: subjects
    26
    23
    23
    22
    72
    Statistical analysis title
    Maribavir 400 mg
    Comparison groups
    Maribavir 400 mg v Valganciclovir 900 mg
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2775
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.63
         upper limit
    5.08
    Statistical analysis title
    Maribavir 800 mg
    Comparison groups
    Maribavir 800 mg v Valganciclovir 900 mg
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7218
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.44
         upper limit
    3.22
    Statistical analysis title
    Maribavir 1200 mg
    Comparison groups
    Maribavir 1200 mg v Valganciclovir 900 mg
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6437
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.46
         upper limit
    3.53
    Statistical analysis title
    Maribavir All Doses
    Comparison groups
    Valganciclovir 900 mg v Maribavir All Doses
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4107
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.62
         upper limit
    3.24

    Primary: Number Of Subjects With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 6 weeks

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    End point title
    Number Of Subjects With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 6 weeks
    End point description
    Plasma CMV DNA was assayed using PCR testing, this method was linear over the range 200-100,000 viral copies/mL with a LLOQ of 200 copies/mL and any results below this LLOQ are referred to as undetectable. Confirmed undetectable plasma CMV DNA (central laboratory) was defined as 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days. Censored observations included subjects who did not meet the criteria for confirmed undetectable plasma CMV DNA within 6 weeks and subjects who discontinued the study for any reason prior to achieving undetectable plasma CMV DNA. ITT-S population.
    End point type
    Primary
    End point timeframe
    Within 6 weeks
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg Maribavir All Doses
    Number of subjects analysed
    40
    40
    39
    40
    119
    Units: subjects
        Subjects with event
    31
    33
    28
    26
    92
        Subjects censored, discontinued
    1
    1
    2
    2
    4
        Subjects censored, ongoing
    7
    6
    8
    11
    21
    Statistical analysis title
    Maribavir 400 mg
    Comparison groups
    Maribavir 400 mg v Valganciclovir 900 mg
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1712
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    6.3
    Statistical analysis title
    Maribavir 800 mg
    Comparison groups
    Maribavir 800 mg v Valganciclovir 900 mg
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0633
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.94
         upper limit
    9.35
    Statistical analysis title
    Maribavir 1200 mg
    Comparison groups
    Maribavir 1200 mg v Valganciclovir 900 mg
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4528
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.53
         upper limit
    4.16
    Statistical analysis title
    Maribavir All Doses
    Comparison groups
    Valganciclovir 900 mg v Maribavir All Doses
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0822
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.91
         upper limit
    4.96

    Secondary: Number Of Subjects With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) at Baseline, Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up (Week 1, 4, 8, 12)

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    End point title
    Number Of Subjects With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) at Baseline, Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up (Week 1, 4, 8, 12)
    End point description
    Plasma CMV DNA was assayed using PCR testing, this method was linear over the range 200-100,000 viral copies/mL with a LLOQ of 200 copies/mL and any results below this LLOQ are referred to as undetectable. Confirmed undetectable plasma CMV DNA (central laboratory) was defined as 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days. Observed and last observation carried forward (LOCF) data were presented. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up (Week 1, 4, 8, 12)
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg Maribavir All Doses
    Number of subjects analysed
    40
    40
    39
    40
    119
    Units: subjects
        Baseline
    4
    4
    2
    4
    10
        Week 1 (observed)
    10
    10
    11
    17
    31
        Week 1 (LOCF)
    0
    0
    0
    0
    0
        Week 2 (observed)
    22
    14
    20
    19
    56
        Week 2 (LOCF)
    0
    0
    1
    2
    1
        Week 3 (observed)
    25
    24
    22
    19
    71
        Week 3 (LOCF)
    3
    1
    4
    6
    8
        Week 4 (observed)
    27
    27
    25
    24
    79
        Week 4 (LOCF)
    6
    4
    6
    7
    16
        Week 5 (observed)
    23
    25
    21
    19
    69
        Week 5 (LOCF)
    11
    9
    10
    13
    30
        Week 6 (observed)
    23
    23
    22
    17
    68
        Week 6 (LOCF)
    11
    10
    10
    15
    31
        Week 8 (observed)
    16
    12
    17
    16
    45
        Week 8 (LOCF)
    17
    20
    14
    17
    51
        Week 10 (observed)
    13
    8
    14
    11
    35
        Week 10 (LOCF)
    18
    24
    17
    21
    59
        Week 12 (observed)
    11
    7
    14
    12
    32
        Week 12 (LOCF)
    20
    25
    17
    21
    62
        Follow-up Week 1 (observed)
    27
    25
    25
    23
    77
        Follow-up Week 1 (LOCF)
    3
    1
    5
    2
    9
        Follow-up Week 4 (observed)
    25
    21
    23
    22
    69
        Follow-up Week 4 (LOCF)
    2
    1
    4
    2
    7
        Follow-up Week 8 (observed)
    26
    27
    27
    21
    80
        Follow-up Week 8 (LOCF)
    3
    3
    6
    4
    12
        Follow-up Week 12 (observed)
    27
    29
    27
    24
    83
        Follow-up Week 12 (LOCF)
    4
    4
    4
    4
    12
    No statistical analyses for this end point

    Secondary: Number Of Subjects With Undetectable Blood/Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) at Baseline, Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up (Week 1, 4, 8, 12)

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    End point title
    Number Of Subjects With Undetectable Blood/Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) at Baseline, Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up (Week 1, 4, 8, 12)
    End point description
    Plasma CMV DNA was assayed using PCR testing, this method was linear over the range 200-100,000 viral copies/mL with a LLOQ of 200 copies/mL and any results below this LLOQ are referred to as undetectable. Observed and LOCF data were presented. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up Week (1, 4, 8, 12)
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg Maribavir All Doses
    Number of subjects analysed
    40
    40
    39
    40
    119
    Units: subjects
        Baseline
    4
    4
    2
    4
    10
        Week 1 (observed)
    10
    10
    11
    17
    31
        Week 1 (LOCF)
    0
    0
    0
    0
    0
        Week 2 (observed)
    22
    14
    20
    20
    56
        Week 2 (LOCF)
    0
    0
    1
    2
    1
        Week 3 (observed)
    25
    24
    22
    19
    71
        Week 3 (LOCF)
    3
    1
    4
    6
    8
        Week 4 (observed)
    28
    27
    25
    24
    80
        Week 4 (LOCF)
    5
    4
    6
    7
    15
        Week 5 (observed)
    24
    27
    21
    20
    72
        Week 5 (LOCF)
    10
    7
    10
    12
    27
        Week 6 (observed)
    23
    23
    22
    17
    68
        Week 6 (LOCF)
    11
    10
    10
    15
    31
        Week 8 (observed)
    17
    13
    18
    16
    48
        Week 8 (LOCF)
    16
    19
    13
    17
    48
        Week 10 (observed)
    13
    8
    14
    11
    35
        Week 10 (LOCF)
    18
    24
    17
    21
    59
        Week 12 (observed)
    11
    7
    14
    12
    32
        Week 12 (LOCF)
    20
    25
    17
    21
    62
        Follow-up Week 1 (observed)
    27
    25
    26
    24
    78
        Follow-up Week 1 (LOCF)
    3
    0
    4
    1
    7
        Follow-up Week 4 (observed)
    25
    22
    23
    22
    70
        Follow-up Week 4 (LOCF)
    1
    0
    4
    2
    5
        Follow-up Week 8 (observed)
    27
    28
    28
    23
    83
        Follow-up Week 8 (LOCF)
    2
    2
    4
    2
    8
        Follow-up Week 12 (observed)
    27
    29
    27
    25
    83
        Follow-up Week 12 (LOCF)
    4
    4
    4
    4
    12
    No statistical analyses for this end point

    Secondary: Number Of Subjects With Cytomegalovirus (CMV) Recurrence Within the Study Participation Period

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    End point title
    Number Of Subjects With Cytomegalovirus (CMV) Recurrence Within the Study Participation Period
    End point description
    CMV recurrence during the study was defined as the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA (central laboratory) after achievement of undetectable plasma CMV DNA (central laboratory) in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1 within the study participation period. Number of subjects analysed included those subjects who had confirmed undetectable CMV DNA. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    33
    34
    31
    28
    Units: subjects
    10
    8
    4
    5
    No statistical analyses for this end point

    Secondary: Number of Subjects With Cytomegalovirus (CMV) Recurrence During The Study

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    End point title
    Number of Subjects With Cytomegalovirus (CMV) Recurrence During The Study
    End point description
    Confirmed undetectable plasma CMV DNA to CMV recurrence during the study was defined as the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA (central laboratory) after achievement of undetectable plasma CMV DNA (central laboratory) in at least 2 consecutive samples, separated by at least 5 days. Censored observations included subjects who did not meet the criteria for CMV recurrence and subjects who discontinued the study for any reason prior to achieving undetectable plasma CMV DNA. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: subjects
        Subjects achieving confirmed undetectable CMV DNA
    33
    34
    31
    28
        Subjects with event
    10
    8
    4
    5
        Subjects censored, discontinued
    2
    3
    4
    2
        Subjects censored, ongoing
    21
    23
    23
    21
    No statistical analyses for this end point

    Secondary: Number of Subjects With Cytomegalovirus (CMV) Recurrence From Last Dose of Study Drug During The Study

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    End point title
    Number of Subjects With Cytomegalovirus (CMV) Recurrence From Last Dose of Study Drug During The Study
    End point description
    Last Dose Of Study Drug To CMV recurrence during the study was defined as the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA (central laboratory) after achievement of undetectable plasma CMV DNA (central laboratory) in at least 2 consecutive samples, separated by at least 5 days, after the last dose of study drug. Censored observations included subjects who did not meet the criteria for CMV recurrence and subjects who discontinued the study for any reason prior to achieving undetectable plasma CMV DNA. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: subjects
        Subjects with CMV recurrence through last dose
    30
    32
    30
    28
        Subjects with event
    8
    6
    4
    5
        Subjects censored, discontinued
    1
    3
    3
    2
        Subjects censored, ongoing
    21
    23
    23
    21
    No statistical analyses for this end point

    Secondary: Number Of Subjects Using Any Non-Study Systemic Anti-Cytomegalovirus (Anti-CMV) Therapies Within 6 Weeks

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    End point title
    Number Of Subjects Using Any Non-Study Systemic Anti-Cytomegalovirus (Anti-CMV) Therapies Within 6 Weeks
    End point description
    Non-study systemic anti-CMV therapies included ganciclovir, valganciclovir, foscarnet, cidofovir, CMV immune globulin (CMV-IGIV, Cytogam®), leflunomide, or artesunate. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Within 6 Weeks
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: subjects
    7
    4
    7
    8
    No statistical analyses for this end point

    Secondary: Number of Days of Use of Non-Study Systemic Anti-Cytomegalovirus (CMV) Therapies after Day 1 and within 6 Weeks

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    End point title
    Number of Days of Use of Non-Study Systemic Anti-Cytomegalovirus (CMV) Therapies after Day 1 and within 6 Weeks
    End point description
    Non-study systemic anti-CMV therapies included ganciclovir, valganciclovir, foscarnet, cidofovir, CMV immune globulin (CMV-IGIV, Cytogam®), leflunomide, or artesunate. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 6
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: days
        arithmetic mean (standard deviation)
    2.6 ± 7.44
    1 ± 5.53
    3.2 ± 9.27
    2.5 ± 7.04
    No statistical analyses for this end point

    Secondary: Time To First Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 6 Weeks: Kaplan Meier Estimate

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    End point title
    Time To First Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 6 Weeks: Kaplan Meier Estimate
    End point description
    Time to first undetectable plasma CMV DNA within 6 Weeks defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days. Median analyzed using Kaplan Meier estimates data were reported. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Within 6 weeks
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: days
    median (confidence interval 95%)
        Kaplan-Meier estimate-Median
    15 (15 to 22)
    22 (16 to 29)
    21 (14 to 22)
    17 (8 to 25)
    No statistical analyses for this end point

    Secondary: Time To First Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 6 Weeks: Median Observed Event Time

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    End point title
    Time To First Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) Within 6 Weeks: Median Observed Event Time
    End point description
    Time to first undetectable plasma CMV DNA within 6 Weeks defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days. Median analyzed using Kaplan Meier estimates data were reported. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Within 6 weeks
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: days
    number (not applicable)
        Median observed event time
    15
    22
    15
    8.5
    No statistical analyses for this end point

    Secondary: Time from Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) to Cytomegalovirus (CMV) Recurrence During The Study

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    End point title
    Time from Confirmed Undetectable Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) to Cytomegalovirus (CMV) Recurrence During The Study
    End point description
    Time from confirmed undetectable plasma CMV DNA to CMV recurrence during the study was defined as the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA (central laboratory) after achievement of undetectable plasma CMV DNA (central laboratory) in at least 2 consecutive samples, separated by at least 5 days, at any time after the confirmed undetectable plasma CMV DNA. Data was presented with median observed event time. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: days
    number (not applicable)
        Median observed event time
    72
    43
    83.5
    80
    No statistical analyses for this end point

    Secondary: Time From Last Dose Of Study Drug To Cytomegalovirus (CMV) Recurrence During The Study

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    End point title
    Time From Last Dose Of Study Drug To Cytomegalovirus (CMV) Recurrence During The Study
    End point description
    Time From Last Dose Of Study Drug To CMV recurrence during the study was defined as the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA (central laboratory) after achievement of undetectable plasma CMV DNA (central laboratory) in at least 2 consecutive samples, separated by at least 5 days, after the last dose of study drug. Data was presented with median observed event time. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: days
    number (not applicable)
        Median observed event time
    28
    7.5
    28
    23
    No statistical analyses for this end point

    Secondary: Change from Baseline in Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) at Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up Week (1, 4, 8, 12)

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    End point title
    Change from Baseline in Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) at Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up Week (1, 4, 8, 12)
    End point description
    Plasma CMV DNA was assayed using PCR testing, this method was linear over the range 200-100,000 viral copies/mL with a LLOQ of 200 copies/mL and any results below this LLOQ are referred to as undetectable. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4, 5, 6, 8, 10, 12, Follow-up Week (1, 4, 8, 12)
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: log10 copies per milliliter
    arithmetic mean (standard deviation)
        Week 1
    -0.7 ± 0.508
    -0.72 ± 0.643
    -0.77 ± 0.579
    -0.63 ± 0.614
        Week 2
    -1.01 ± 0.773
    -0.85 ± 0.804
    -1.02 ± 0.859
    -0.86 ± 0.795
        Week 3
    -1.24 ± 0.853
    -1.31 ± 0.816
    -1.19 ± 0.82
    -1.09 ± 0.841
        Week 4
    -1.35 ± 0.911
    -1.5 ± 0.909
    -1.27 ± 0.921
    -1.18 ± 0.921
        Week 5
    -1.34 ± 0.917
    -1.56 ± 0.961
    -1.27 ± 0.921
    -1.19 ± 0.934
        Week 6
    -1.28 ± 0.957
    -1.52 ± 1.033
    -1.28 ± 0.921
    -1.2 ± 0.939
        Week 8
    -1.26 ± 0.959
    -1.48 ± 1.013
    -1.26 ± 0.924
    -1.21 ± 0.938
        Week 10
    -1.2 ± 0.969
    -1.45 ± 1.005
    -1.25 ± 0.937
    -1.2 ± 0.929
        Week 12
    -1.18 ± 0.982
    -1.4 ± 1.061
    -1.23 ± 0.958
    -1.23 ± 0.935
        Follow-up Week 1
    -1.19 ± 0.983
    -1.28 ± 1.031
    -1.26 ± 0.909
    -1.18 ± 0.856
        Follow-up Week 4
    -1.19 ± 0.916
    -1.08 ± 1.097
    -1.38 ± 0.943
    -0.93 ± 0.909
        Follow-up Week 8
    -1.2 ± 0.999
    -1.53 ± 0.942
    -1.42 ± 0.973
    -0.95 ± 1.045
        Follow-up Week 12
    -1.23 ± 0.894
    -1.55 ± 0.905
    -1.43 ± 0.975
    -1.14 ± 0.947
    No statistical analyses for this end point

    Secondary: Rate Of Change In Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) At Weeks 3 And 6

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    End point title
    Rate Of Change In Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) At Weeks 3 And 6
    End point description
    Rate of change in plasma CMV DNA was measured by change from baseline divided by number of weeks. Mean rate of change in plasma CMV DNA is reported. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Week 3 and 6
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: log10 Copies/mL per Week
    arithmetic mean (confidence interval 95%)
        Week 3
    -0.41 (-0.5 to -0.32)
    -0.44 (-0.52 to -0.35)
    -0.4 (-0.49 to -0.31)
    -0.36 (-0.45 to -0.27)
        Week 6
    -0.21 (-0.26 to -0.16)
    -0.25 (-0.31 to -0.2)
    -0.21 (-0.26 to -0.16)
    -0.2 (-0.25 to -0.15)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change in Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) At Weeks 3 And 6

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    End point title
    Number of Subjects With Change in Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (Central Laboratory) At Weeks 3 And 6
    End point description
    Data was presented for number of subjects with LOCF. ITT-S population.
    End point type
    Secondary
    End point timeframe
    Week 3 and 6
    End point values
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Number of subjects analysed
    40
    40
    39
    40
    Units: subjects
    7
    3
    10
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Follow-up Week 24
    Adverse event reporting additional description
    National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    NCI CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Maribavir 400 mg
    Reporting group description
    Maribavir 400 mg table orally twice daily up to 12 weeks

    Reporting group title
    Maribavir 800 mg
    Reporting group description
    Maribavir 800 mg table orally twice daily up to 12 weeks

    Reporting group title
    Maribavir 1200 mg
    Reporting group description
    Maribavir 1200 mg table orally twice daily up to 12 weeks

    Reporting group title
    Valganciclovir 900 mg
    Reporting group description
    Valganciclovir 900 mg tablet orally twice daily for three weeks and post that daily once up to 12 weeks.

    Serious adverse events
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 40 (40.00%)
    17 / 40 (42.50%)
    19 / 39 (48.72%)
    13 / 40 (32.50%)
         number of deaths (all causes)
    2
    1
    3
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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 / 1
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 39 (7.69%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Kidney transplant rejection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver transplant rejection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    General disorders and administration site conditions
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multi-Organ failure
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Infusion related reaction
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    C-Reactive protein increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immunosuppressant drug level increased
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Dyspnoea
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Blood and lymphatic system disorders
    Aplasia pure red cell
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Nephrogenic anaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Toxic encephalopathy
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Vomiting
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Hepatic artery thrombosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Osteolysis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Diabetes mellitus
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Bacterial sepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    3 / 40 (7.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary abscess
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Biliary sepsis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Bk virus infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Bronchiolitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus gastroenteritis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Gastroenteritis
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Hepatitis c
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Herpes zoster
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Oral herpes
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (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
    Pneumonia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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 abscess
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    0 / 40 (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
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxoplasmosis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (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
    Urinary tract infection
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    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
    Maribavir 400 mg Maribavir 800 mg Maribavir 1200 mg Valganciclovir 900 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 40 (95.00%)
    36 / 40 (90.00%)
    37 / 39 (94.87%)
    28 / 40 (70.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    2 / 39 (5.13%)
    3 / 40 (7.50%)
         occurrences all number
    2
    2
    2
    4
    Hypertension
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    1 / 40 (2.50%)
         occurrences all number
    3
    0
    2
    1
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
    3 / 40 (7.50%)
         occurrences all number
    4
    1
    1
    4
    Kidney transplant rejection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    2
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
         occurrences all number
    1
    3
    1
    1
    Malaise
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    2 / 39 (5.13%)
    1 / 40 (2.50%)
         occurrences all number
    2
    3
    2
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 40 (7.50%)
    9 / 40 (22.50%)
    5 / 39 (12.82%)
    7 / 40 (17.50%)
         occurrences all number
    4
    10
    5
    7
    Pyrexia
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    4 / 39 (10.26%)
    0 / 40 (0.00%)
         occurrences all number
    3
    2
    4
    0
    Psychiatric disorders
    Apathy
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Insomnia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    3
    0
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Wound
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    2 / 40 (5.00%)
         occurrences all number
    1
    0
    2
    2
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    1
    0
    2
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    0 / 39 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3
    0
    3
    C-Reactive protein increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Immunosuppressant drug level increased
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    5 / 39 (12.82%)
    0 / 40 (0.00%)
         occurrences all number
    2
    2
    6
    0
    Weight decreased
         subjects affected / exposed
    6 / 40 (15.00%)
    2 / 40 (5.00%)
    3 / 39 (7.69%)
    3 / 40 (7.50%)
         occurrences all number
    6
    2
    3
    3
    Weight increased
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    2
    1
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 40 (12.50%)
    6 / 40 (15.00%)
    6 / 39 (15.38%)
    5 / 40 (12.50%)
         occurrences all number
    7
    6
    6
    6
    Dyspnoea
         subjects affected / exposed
    3 / 40 (7.50%)
    3 / 40 (7.50%)
    6 / 39 (15.38%)
    1 / 40 (2.50%)
         occurrences all number
    3
    3
    6
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    7 / 40 (17.50%)
    3 / 39 (7.69%)
    1 / 40 (2.50%)
         occurrences all number
    2
    7
    3
    1
    Leukopenia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    2
    2
    0
    3
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Neutropenia
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    1 / 39 (2.56%)
    2 / 40 (5.00%)
         occurrences all number
    1
    3
    1
    2
    Thrombocytopenia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    1
    1
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Dysgeusia
         subjects affected / exposed
    18 / 40 (45.00%)
    16 / 40 (40.00%)
    14 / 39 (35.90%)
    1 / 40 (2.50%)
         occurrences all number
    19
    16
    16
    1
    Headache
         subjects affected / exposed
    4 / 40 (10.00%)
    4 / 40 (10.00%)
    6 / 39 (15.38%)
    1 / 40 (2.50%)
         occurrences all number
    4
    4
    6
    2
    Paraesthesia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 39 (7.69%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    3
    1
    Tremor
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    4 / 39 (10.26%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    4
    1
    Syncope
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    2
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    2 / 40 (5.00%)
         occurrences all number
    0
    0
    2
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    4 / 39 (10.26%)
    3 / 40 (7.50%)
         occurrences all number
    2
    4
    4
    3
    Abdominal pain upper
         subjects affected / exposed
    4 / 40 (10.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
         occurrences all number
    4
    2
    1
    1
    Constipation
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    4 / 39 (10.26%)
    2 / 40 (5.00%)
         occurrences all number
    2
    4
    4
    2
    Diarrhoea
         subjects affected / exposed
    7 / 40 (17.50%)
    6 / 40 (15.00%)
    8 / 39 (20.51%)
    4 / 40 (10.00%)
         occurrences all number
    8
    7
    9
    4
    Dry mouth
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    2 / 39 (5.13%)
    3 / 40 (7.50%)
         occurrences all number
    1
    2
    2
    3
    Dyspepsia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Nausea
         subjects affected / exposed
    9 / 40 (22.50%)
    7 / 40 (17.50%)
    11 / 39 (28.21%)
    6 / 40 (15.00%)
         occurrences all number
    10
    8
    13
    6
    Stomatitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vomiting
         subjects affected / exposed
    4 / 40 (10.00%)
    7 / 40 (17.50%)
    11 / 39 (28.21%)
    4 / 40 (10.00%)
         occurrences all number
    5
    7
    15
    4
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    3 / 39 (7.69%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    3
    1
    Nocturia
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Proteinuria
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Renal failure
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    4 / 39 (10.26%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    4
    0
    Renal impairment
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    3
    0
    0
    1
    Rash
         subjects affected / exposed
    2 / 40 (5.00%)
    4 / 40 (10.00%)
    1 / 39 (2.56%)
    3 / 40 (7.50%)
         occurrences all number
    4
    4
    1
    4
    Pruritus
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    2
    2
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
         occurrences all number
    0
    2
    1
    1
    Muscular weakness
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    1
    0
    2
    Myalgia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    0
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 40 (10.00%)
    5 / 40 (12.50%)
    4 / 39 (10.26%)
    1 / 40 (2.50%)
         occurrences all number
    4
    5
    4
    1
    Diabetes mellitus
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    2
    1
    Hypercalcaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Hypokalaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    5 / 39 (12.82%)
    2 / 40 (5.00%)
         occurrences all number
    2
    1
    7
    2
    Metabolic acidosis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 39 (7.69%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    0
    0
    3
    Cytomegalovirus infection
         subjects affected / exposed
    3 / 40 (7.50%)
    3 / 40 (7.50%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
         occurrences all number
    3
    3
    1
    1
    Herpes zoster
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 40 (17.50%)
    5 / 40 (12.50%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    8
    5
    0
    2
    Oral candidiasis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pneumonia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
    2 / 40 (5.00%)
         occurrences all number
    2
    0
    1
    2
    Oral herpes
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    3
    2
    2
    0
    Rhinitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    1
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    1
    0
    2
    Urinary tract infection
         subjects affected / exposed
    5 / 40 (12.50%)
    4 / 40 (10.00%)
    5 / 39 (12.82%)
    4 / 40 (10.00%)
         occurrences all number
    6
    5
    6
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2013
    Added a new protocol section to clarify medications that were used for prevention or treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections during the study.

    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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