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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

    Summary
    EudraCT number
    		 2015-004725-13
    Trial protocol
    		 DE   GB   BE   ES   FR   AT   HR   IT   DK  
    Global end of trial date
    17 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Aug 2021
    First version publication date
    25 Aug 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SHP620-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02931539
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 Shire Way, Lexington, United States, MA 02421
    Public contact
    Study Director, Shire, ClinicalTransparency@takeda.com
    Scientific contact
    Study Director, Shire, ClinicalTransparency@takeda.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
    17 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to compare the efficacy of maribavir to Investigator-assigned Anti-CMV Treatment (IAT) (control) in CMV viremia clearance at the end of Study Week 8 in transplant recipients who were refractory or resistant to prior anti-CMV treatment.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and in compliance with all applicable industry regulations, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996), European Union (EU) Directive 2001/20/EC, as well as all applicable national and local laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2016
    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
    United States: 191
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    Belgium: 31
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    France: 49
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Croatia: 2
    Worldwide total number of subjects
    352
    EEA total number of subjects
    122
    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)
    282
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 94 sites in North America, Europe, and Asia Pacific between 22 December 2016 (first subject first visit) and 17 August 2020 (last subject last visit).

    Pre-assignment
    Screening details
    		 Subjects with CMV infections were randomized into 2 treatment groups: IAT and Maribavir 400mg. Subjects randomized to IAT arm, were considered eligible for entry into Maribavir rescue arm at Week 3 if met the criteria for worsening of CMV infection based on medical monitor review. As planned, combined data has been reported for IAT control group.

    Period 1
    Period 1 title
    Period 1: Treatment Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigator-assigned Anti-CMV Treatment (IAT)
    Arm description
    		 Subjects received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ganciclovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received ganciclovir intravenously based on the the investigator's discretion for the 8 week treatment period.

    Investigational medicinal product name
    Valganciclovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received valganciclovir orally based on the the investigator's discretion for the 8 week treatment period.

    Investigational medicinal product name
    Foscarnet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received foscarnet intravenously based on investigator's discretion for the 8 week treatment period.

    Investigational medicinal product name
    Cidofovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received cidofovir intravenously based on the investigator's discretion for the 8 week treatment period.

    Arm title
    		 Maribavir 400 mg
    Arm description
    		 Subjects received maribavir 400 milligram (mg) (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maribavir
    Investigational medicinal product code
    SHP620
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.

    Number of subjects in period 1
    		Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Started
    117
    235
    Treated Subjects
    116
    234
    Completed
    58
    199
    Not completed
    59
    36
         Adverse event, serious fatal
    8
    24
         Consent withdrawn by subject
    16
    8
         Adverse event, non-fatal
    5
    1
         Subjects transitioned into maribavir rescue arm
    22
    -
         Lost to follow-up
    1
    2
         Investigator discretion
    1
    1
         Protocol deviation
    6
    -
    Period 2
    Period 2 title
    Period 2: Maribavir Rescue Therapy
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Maribavir Rescue Arm
    Arm description
    		 Subjects with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maribavir
    Investigational medicinal product code
    SHP620
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.

    Number of subjects in period 2 [1]
    		Maribavir Rescue Arm
    Started
    22
    Completed
    20
    Not completed
    2
         Sponsor decision
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all subjects who completed the treatment phase entered the Maribavir Rescue Therapy. No subjects from the Maribavir 400 mg entered the Maribavir Rescue Therapy.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Investigator-assigned Anti-CMV Treatment (IAT)
    Reporting group description
    		 Subjects received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.

    Reporting group title
    Maribavir 400 mg
    Reporting group description
    		 Subjects received maribavir 400 milligram (mg) (2*200 mg tablets), orally, twice daily for the 8 week treatment period.

    Reporting group values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg Total
    Number of subjects
    		 117 235
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.5 ( 12.80 ) 53.8 ( 13.39 ) -
    Sex: Female, Male
    Units: subjects
        Female
    		 52 87 139
        Male
    		 65 148 213
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 14 21
        Not Hispanic or Latino
    		 95 198 293
        Unknown or Not Reported
    		 15 23 38
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 7 9 16
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 18 29 47
        White
    		 87 179 266
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 5 18 23

    End points

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    End points reporting groups
    Reporting group title
    Investigator-assigned Anti-CMV Treatment (IAT)
    Reporting group description
    		 Subjects received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.

    Reporting group title
    Maribavir 400 mg
    Reporting group description
    		 Subjects received maribavir 400 milligram (mg) (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
    Reporting group title
    Maribavir Rescue Arm
    Reporting group description
    		 Subjects with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.

    Primary: Percentage of Subjects who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at end of Week 8

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    End point title
    		 Percentage of Subjects who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at end of Week 8
    End point description
    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (<) lower limit of quantification (LLOQ) that is, <137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of subjects with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, and could not have received alternative anti-CMV treatment were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
        number (not applicable)
    23.9
    55.7
    Statistical analysis title
    		 Difference in percentage of responders
    Comparison groups
    Investigator-assigned Anti-CMV Treatment (IAT) v Maribavir 400 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage of responders
    Point estimate
    32.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.8
         upper limit
    		 42.74

    Secondary: Percentage of Subjects who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at end of Week 8, Followed by Maintenance of Treatment Effect at Week 16

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    End point title
    		 Percentage of Subjects who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at end of Week 8, Followed by Maintenance of Treatment Effect at Week 16
    End point description
    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for subjects symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for subjects asymptomatic at baseline. Percentage of subjects who achieved confirmed CMV viremia clearance and CMV infection symptom control at end of Week 8, followed by maintenance of treatment effect at Week 16. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    Up to Week 16
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
        number (not applicable)
    10.3
    18.7
    Statistical analysis title
    		 Difference in percentage of responders
    Comparison groups
    Investigator-assigned Anti-CMV Treatment (IAT) v Maribavir 400 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage of responders
    Point estimate
    9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.02
         upper limit
    		 16.88

    Secondary: Percentage of Subjects who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment

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    End point title
    		 Percentage of Subjects who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment
    End point description
    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of subjects who achieved confirmed CMV viremia clearance after receiving 8 weeks study-assigned treatment at end of Week 8, and maintained this effect through 12, 16 and 20 were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    At Week 8 through Weeks 12, 16 and 20
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
    number (not applicable)
        At Week 8
    18.8
    54.9
        At Week 12
    5.1
    22.6
        At Week 16
    5.1
    18.7
        At Week 20
    4.3
    18.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20

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    End point title
    		 Percentage of Subjects who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20
    End point description
    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for subjects symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for subjects asymptomatic at baseline. Percentage of subjects who achieved confirmed CMV viremia clearance and CMV infection control after receiving 8 weeks study-assigned treatment at end of Week 8, and maintained this effect through 12, 16 and 20 were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    At Week 8 through Weeks 12, 16 and 20
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
    number (not applicable)
        At Week 8
    18.8
    54.9
        At Week 12
    5.1
    22.6
        At Week 16
    5.1
    18.7
        At Week 20
    4.3
    18.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy

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    End point title
    		 Percentage of Subjects who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy
    End point description
    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for subjects symptomatic at baseline or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for subjects asymptomatic at baseline. Percentage of subjects who maintained CMV viremia clearance and CMV infection symptom control at the end of study Week 8 through Weeks 12 and 20 regardless of whether either study-assigned treatment was discontinued before 8 weeks of therapy were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 12 and 20
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
    number (not applicable)
        At Week 8
    23.9
    55.7
        At Week 12
    10.3
    22.6
        At Week 20
    9.4
    18.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy

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    End point title
    		 Percentage of Subjects With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of subjects with recurrence of CMV viremia during the first 8 weeks of study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    At Week 8
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
        number (not applicable)
    12.3
    17.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy

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    End point title
    		 Percentage of Subjects With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of subjects with recurrence of CMV viremia during the 12 weeks follow-up period regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    End of Week 8 up to Week 20 (12 weeks follow up period)
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
        number (not applicable)
    21.5
    38.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Recurrence of CMV Viremia at any Time on Study Regardless of Whether Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy

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    End point title
    		 Percentage of Subjects With Recurrence of CMV Viremia at any Time on Study Regardless of Whether Study-assigned Treatment was Discontinued Before 8 Weeks of Therapy
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of subjects with recurrence of CMV viremia during at any time on study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 20
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
        number (not applicable)
    33.8
    56.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment

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    End point title
    		 Percentage of Subjects who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of subjects with recurrence of CMV viremia during the first 8 Weeks of the treatment who completed 8 weeks of study-assigned treatment was reported. Percentage of subjects with recurrence of CMV viremia during the first 8 Weeks of the treatment who completed 8 weeks of study-assigned treatment were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study. Here “number of subjects analyzed” were subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 8
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    37
    183
    Units: percentage of subjects
        number (not applicable)
    9.7
    15.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period

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    End point title
    		 Percentage of Subjects who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of subjects who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 12 weeks of follow-up period were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study. Here “number of subjects analysed” were subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    End of Week 8 up to Week 20 (12 weeks follow-up period)
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    37
    183
    Units: percentage of subjects
        number (not applicable)
    35.5
    40.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study

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    End point title
    		 Percentage of Subjects who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of subjects who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 20 weeks of study were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study. Here “number of subjects analysed” were subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 20
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    37
    183
    Units: percentage of subjects
        number (not applicable)
    45.2
    56.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Recurrence of CMV Viremia While on Study-assigned Treatment

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    End point title
    		 Percentage of Subjects With Recurrence of CMV Viremia While on Study-assigned Treatment
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of subjects with recurrence of CMV viremia during study-assigned treatment period was reported. Percentage of subjects with recurrence of CMV viremia while on study-assigned treatment period were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    Baseline up to termination of study treatment (up to Week 8)
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
        number (not applicable)
    4.6
    15.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Recurrence of CMV Viremia While off Study-assigned Treatment During Follow-up Period

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    End point title
    		 Percentage of Subjects With Recurrence of CMV Viremia While off Study-assigned Treatment During Follow-up Period
    End point description
    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of subjects with recurrence of CMV viremia while off study-assigned treatment during follow-up period were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    Termination of study treatment (Week 8) up to the End of the Study (Week 20)
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: percentage of subjects
        number (not applicable)
    29.2
    40.8
    No statistical analyses for this end point

    Secondary: Number of Subjects who had Maribavir CMV Resistance at Baseline

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    End point title
    		 Number of Subjects who had Maribavir CMV Resistance at Baseline
    End point description
    Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of subjects who had maribavir CMV resistance at baseline was reported. The combination of maribavir resistance set (MRS) and non-MRS set (MRS+non-MRS) included all subjects in modified randomized set who had been randomized in the study and who had taken any dose of study-assigned treatment with evaluable CMV genotypic data at baseline with or without pre-existing known maribavir RASs in pUL97 and/or pUL27. Here “number of subjects analysed” were subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    At Baseline
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    100
    17
    214
    Units: subjects
        RASs associated with pUL97 only
    3
    1
    0
        RASs associated with pUL27 only
    0
    0
    1
        RASs associated with pUL97 and pUL27
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects who had Post-baseline Resistance to Maribavir

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    End point title
    		 Number of Subjects who had Post-baseline Resistance to Maribavir
    End point description
    Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of subjects who had postbaseline resistance to maribavir was reported. The combination of maribavir resistance set (MRS) and non-MRS set (MRS+non-MRS) included all subjects in modified randomized set who had been randomized in the study and who had taken any dose of study-assigned treatment with evaluable CMV genotypic data at baseline with or without pre-existing known maribavir RASs in pUL97 and/or pUL27. Here “number of subjects analysed” were subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    After first dose of study drug up to Week 20
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    100
    17
    214
    Units: subjects
        RASs associated with pUL97 only
    0
    4
    45
        RASs associated with pUL27 only
    0
    0
    0
        RASs associated with pUL97 and pUL27
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With All-cause Mortality by the End of the Study

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    End point title
    		 Number of Subjects With All-cause Mortality by the End of the Study
    End point description
    All-cause mortality was analysed by the end of study regardless of the use of rescue treatment or alternative anti-CMV treatment. Number of subjects who died during the entire study period were reported. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    From enrollment up to end of study (approximately 44 months)
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: subjects
    13
    27
    No statistical analyses for this end point

    Secondary: Time to all Cause Mortality

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    End point title
    		 Time to all Cause Mortality
    End point description
    The time to all-cause mortality by the end of the study participation in days was calculated. Subjects who were alive at the last study follow-up (regardless of use of rescue or alternative anti-CMV treatment), withdrew from study or were lost to follow-up were censored at the date of last contact. The randomized set consisted of all subjects who had signed informed consent and had begun some study procedures and were randomized to the study.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 20
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir 400 mg
    Number of subjects analysed
    117
    235
    Units: days
        median (full range (min-max))
    73.0 (13.0 to 186.0)
    55.0 (3.0 to 182.0)
    Statistical analysis title
    		 Time to Death
    Comparison groups
    Investigator-assigned Anti-CMV Treatment (IAT) v Maribavir 400 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.647
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.549
         upper limit
    		 2.357

    Secondary: Percentage of Subjects who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at end of Week 8 After Starting Maribavir Rescue Treatment

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    End point title
    		 Percentage of Subjects who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at end of Week 8 After Starting Maribavir Rescue Treatment
    End point description
    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether the rescue treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of subjects who achieved confirmed CMV viremia clearance at end of Week 8 after starting maribavir rescue treatment were reported. The rescue set consisted of all subjects who entered the rescue arm and received any dose of maribavir as rescue therapy. As planned, this end point was assessed only in maribavir rescue arm.
    End point type
    Secondary
    End point timeframe
    From start of maribavir rescue treatment through 8 weeks
    End point values
    		 Maribavir Rescue Arm
    Number of subjects analysed
    22
    Units: percentage of subjects
        number (confidence interval 95%)
    50.0 (28.22 to 71.78)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Receiving Maribavir Rescue Treatment who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 With Maintenance of Effect Through Week 16

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    End point title
    		 Percentage of Subjects Receiving Maribavir Rescue Treatment who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 With Maintenance of Effect Through Week 16
    End point description
    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for subjects symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for subjects asymptomatic at baseline. Percentage of subjects receiving maribavir rescue treatment who achieved confirmed CMV viremia clearance and CMV infection symptom control at Week 8 with maintenance of effect through Week 16 were reported. The rescue set consisted of all subjects who entered the rescue arm and received any dose of maribavir as rescue therapy. As planned, this end point was assessed only in maribavir rescue arm.
    End point type
    Secondary
    End point timeframe
    Up to Week 16
    End point values
    		 Maribavir Rescue Arm
    Number of subjects analysed
    22
    Units: percentage of subjects
    number (confidence interval 95%)
        At Week 16
    27.3 (10.73 to 50.22)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period

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    End point title
    		 Number of Subjects with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE was any untoward medical occurrence (whether considered to be related to study-assigned treatment or not) that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital abnormality/birth defect, or was an important medical event. TEAEs was defined as any adverse events (classified by preferred term) that had a start date on or after the first dose of study treatment or that had a start date before the date of first dose of study treatment, but increased in severity after the first dose of study treatment. The safety set consisted of all subjects who had taken any dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline up to 7 days or 21 days (if cidofovir used) after the last dose of study treatment (up to Week 8)
    End point values
    		 Investigator-assigned Anti-CMV Treatment (IAT) Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    116
    22
    234
    Units: subjects
        TEAEs
    106
    22
    228
        Serious TEAEs
    43
    11
    90
    No statistical analyses for this end point

    Secondary: Predose Concentration (Cmin) of Maribavir

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    End point title
    		 Predose Concentration (Cmin) of Maribavir [1]
    End point description
    Cmin of maribavir was reported. The pharmacokinetic set consisted of all subjects who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. Here “number of subjects analysed” were subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Predose at Week 1, 4 and 8
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    20
    208
    Units: micrograms per milliliter (mcg/mL)
    arithmetic mean (standard deviation)
        Cmin at Week 1 (n =20, 208)
    8.57 ( 6.28 )
    8.77 ( 7.88 )
        Cmin at Week 4 (n =16, 177)
    5.75 ( 3.99 )
    7.59 ( 7.05 )
        Cmin at Week 8 (n =18, 168)
    5.65 ( 4.47 )
    7.19 ( 6.41 )
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) of Marivabir for Adolescent Subjects

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    End point title
    		 Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) of Marivabir for Adolescent Subjects [2]
    End point description
    AUC0-tau of maribavir for adolescent subjects was planned to be reported. The pharmacokinetic set consisted of all subjects who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This end point was planned to be analysed only in adolescent subjects. Data was not collected and analysed as adolescent subjects were not enrolled in this study.
    End point type
    Secondary
    End point timeframe
    Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose, Week 4: Pre-morning dose, and Week 8: Pre-morning dose and 2-4 hour post morning dose
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: hour*microgram per milliliter (h*mcg/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [3] - No subject was analysed, as none of the adolescents subject were enrolled.
    [4] - No subject was analysed, as none of the adolescents subject were enrolled.
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of Maribavir for Adolescent Subjects

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Maribavir for Adolescent Subjects [5]
    End point description
    Cmax of maribavir for adolescent subjects was planned to be reported. The pharmacokinetic set consisted of all subjects who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This end point was planned to be analysed only in adolescent subjects. Data was not collected and analysed as adolescent subjects were not enrolled in this study.
    End point type
    Secondary
    End point timeframe
    Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: micrograms per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [6] - No subject was analysed, as none of the adolescents subject were enrolled.
    [7] - No subject was analysed, as none of the adolescents subject were enrolled.
    No statistical analyses for this end point

    Secondary: Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Subjects

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    End point title
    		 Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Subjects [8]
    End point description
    Tmax of maribavir for adolescent subjects was planned to be reported. The pharmacokinetic set consisted of all subjects who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This end point was planned to be analysed only in adolescent subjects. Data was not collected and analysed as adolescent subjects were not enrolled in this study.
    End point type
    Secondary
    End point timeframe
    Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: hours
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [9] - No subject was analysed, as none of the adolescents subject were enrolled.
    [10] - No subject was analysed, as none of the adolescents subject were enrolled.
    No statistical analyses for this end point

    Secondary: Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Subjects

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    End point title
    		 Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Subjects [11]
    End point description
    Apparent oral clearance (CL/F) of maribavir for adolescent subjects was planned to be reported. The pharmacokinetic set consisted of all subjects who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This end point was planned to be analysed only in adolescent subjects. Data was not collected and analysed as adolescent subjects were not enrolled in this study.
    End point type
    Secondary
    End point timeframe
    Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: liter per hour (L/h)
        median (standard deviation)
    ( )
    ( )
    Notes
    [12] - No subject was analysed, as none of the adolescents subject were enrolled.
    [13] - No subject was analysed, as none of the adolescents subject were enrolled.
    No statistical analyses for this end point

    Secondary: Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Subjects

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    End point title
    		 Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Subjects [14]
    End point description
    Apparent volume of distribution (Vz/F) of maribavir for adolescent subjects was planned to be reported. The pharmacokinetic set consisted of all subjects who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This end point was planned to be analysed only in adolescent subjects. Data was not collected and analysed as adolescent subjects were not enrolled in this study.
    End point type
    Secondary
    End point timeframe
    Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Maribavir Rescue Arm Maribavir 400 mg
    Number of subjects analysed
    0 [15]
    0 [16]
    Units: liter (L)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [15] - No subject was analysed, as none of the adolescents subject were enrolled.
    [16] - No subject was analysed, as none of the adolescents subject were enrolled.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to end of study (approximately 44 months)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    IAT: Ganciclovir/ Valganciclovir
    Reporting group description
    		 Subjects received ganciclovir intravenously or valganciclovir orally based on the the investigator's discretion for the 8 week treatment period.

    Reporting group title
    IAT: Foscarnet
    Reporting group description
    		 Subjects received foscarnet intravenously based on investigator's discretion for the 8 week treatment period.

    Reporting group title
    IAT: Cidofovir
    Reporting group description
    		 Subjects received cidofovir intravenously based on the investigator's discretion for the 8 week treatment period.

    Reporting group title
    IAT: Foscarnet + Ganciclovir/ Valganciclovir
    Reporting group description
    		 Subjects received foscarnet intravenously in combination with ganciclovir intravenously or valganciclovir orally based on investigator's discretion for the 8 week treatment period.

    Reporting group title
    Maribavir 400 mg
    Reporting group description
    		 Subjects received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.

    Reporting group title
    Maribavir Rescue Arm
    Reporting group description
    		 Subjects with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeds of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.

    Serious adverse events
    		 IAT: Ganciclovir/ Valganciclovir IAT: Foscarnet IAT: Cidofovir IAT: Foscarnet + Ganciclovir/ Valganciclovir Maribavir 400 mg Maribavir Rescue Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 56 (58.93%)
    26 / 47 (55.32%)
    3 / 6 (50.00%)
    1 / 7 (14.29%)
    131 / 234 (55.98%)
    14 / 22 (63.64%)
         number of deaths (all causes)
    6
    7
    0
    0
    27
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia recurrent
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia recurrent
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma recurrent
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug interaction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    6 / 234 (2.56%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Treatment failure
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in liver
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 234 (1.71%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    General physical condition abnormal
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immunosuppressant drug level increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral load increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incorrect dose administered
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transplant dysfunction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transplant failure
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 234 (1.71%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile bone marrow aplasia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    8 / 234 (3.42%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 0
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileal perforation
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 56 (0.00%)
    6 / 47 (12.77%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    13 / 234 (5.56%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 6
    0 / 0
    0 / 0
    3 / 14
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc compression
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BK virus infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus chorioretinitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    5 / 234 (2.14%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    9 / 234 (3.85%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    1 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus mucocutaneous ulcer
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus syndrome
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    12 / 234 (5.13%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    2 / 13
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis cytomegalovirus
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    5 / 234 (2.14%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster meningoencephalitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 234 (1.71%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cryptococcal
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral toxoplasmosis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus enterocolitis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus gastroenteritis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus gastrointestinal infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fungal skin infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Septic arthritis staphylococcal
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis fungal
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal osteomyelitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stenotrophomonas infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acidosis hyperchloraemic
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IAT: Ganciclovir/ Valganciclovir IAT: Foscarnet IAT: Cidofovir IAT: Foscarnet + Ganciclovir/ Valganciclovir Maribavir 400 mg Maribavir Rescue Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 56 (96.43%)
    43 / 47 (91.49%)
    5 / 6 (83.33%)
    7 / 7 (100.00%)
    229 / 234 (97.86%)
    22 / 22 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 56 (3.57%)
    6 / 47 (12.77%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    15 / 234 (6.41%)
    1 / 22 (4.55%)
         occurrences all number
    2
    7
    0
    1
    15
    2
    Hypotension
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 47 (4.26%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    11 / 234 (4.70%)
    1 / 22 (4.55%)
         occurrences all number
    4
    2
    1
    0
    13
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 56 (17.86%)
    5 / 47 (10.64%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    36 / 234 (15.38%)
    3 / 22 (13.64%)
         occurrences all number
    10
    5
    0
    1
    38
    3
    Oedema peripheral
         subjects affected / exposed
    5 / 56 (8.93%)
    7 / 47 (14.89%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    26 / 234 (11.11%)
    3 / 22 (13.64%)
         occurrences all number
    7
    10
    0
    2
    27
    3
    Pyrexia
         subjects affected / exposed
    12 / 56 (21.43%)
    10 / 47 (21.28%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    32 / 234 (13.68%)
    5 / 22 (22.73%)
         occurrences all number
    15
    11
    2
    0
    48
    6
    Chills
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    1
    0
    2
    1
    Gait disturbance
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Temperature intolerance
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Asthenia
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    17 / 234 (7.26%)
    0 / 22 (0.00%)
         occurrences all number
    3
    3
    0
    0
    20
    0
    Device related thrombosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Graft versus host disease
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences all number
    3
    3
    0
    0
    2
    0
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    6 / 234 (2.56%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    6
    0
    Transplant rejection
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    8 / 234 (3.42%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    9
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 56 (12.50%)
    4 / 47 (8.51%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    22 / 234 (9.40%)
    5 / 22 (22.73%)
         occurrences all number
    7
    4
    1
    1
    28
    5
    Dyspnoea
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 47 (8.51%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    23 / 234 (9.83%)
    0 / 22 (0.00%)
         occurrences all number
    5
    4
    0
    0
    24
    0
    Epistaxis
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 234 (1.71%)
    1 / 22 (4.55%)
         occurrences all number
    5
    3
    0
    0
    6
    1
    Nasal congestion
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    1
    8
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    0
    1
    7
    1
    Insomnia
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 234 (1.71%)
    1 / 22 (4.55%)
         occurrences all number
    2
    3
    0
    0
    4
    1
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 47 (8.51%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    18 / 234 (7.69%)
    1 / 22 (4.55%)
         occurrences all number
    4
    5
    0
    1
    19
    1
    Immunosuppressant drug level increased
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    21 / 234 (8.97%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    23
    0
    Blood calcium decreased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Clostridium test positive
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    0
    1
    1
    Platelet count decreased
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    5 / 234 (2.14%)
    1 / 22 (4.55%)
         occurrences all number
    5
    4
    0
    0
    6
    1
    White blood cell count decreased
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    2 / 22 (9.09%)
         occurrences all number
    2
    0
    1
    0
    2
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences all number
    3
    1
    0
    0
    7
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 234 (1.71%)
    0 / 22 (0.00%)
         occurrences all number
    3
    1
    0
    0
    4
    0
    Blood urea increased
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    4 / 234 (1.71%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    1
    4
    0
    Transaminases increased
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    5 / 234 (2.14%)
    1 / 22 (4.55%)
         occurrences all number
    2
    3
    0
    0
    5
    1
    Weight decreased
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    8 / 234 (3.42%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    1
    0
    12
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    9 / 234 (3.85%)
    0 / 22 (0.00%)
         occurrences all number
    4
    1
    0
    0
    9
    0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 56 (12.50%)
    2 / 47 (4.26%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    20 / 234 (8.55%)
    1 / 22 (4.55%)
         occurrences all number
    7
    2
    1
    3
    23
    1
    Dysgeusia
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    88 / 234 (37.61%)
    1 / 22 (4.55%)
         occurrences all number
    4
    0
    1
    1
    95
    1
    Headache
         subjects affected / exposed
    9 / 56 (16.07%)
    9 / 47 (19.15%)
    0 / 6 (0.00%)
    3 / 7 (42.86%)
    30 / 234 (12.82%)
    2 / 22 (9.09%)
         occurrences all number
    11
    10
    0
    3
    34
    3
    Taste disorder
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    21 / 234 (8.97%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    21
    0
    Aura
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 56 (1.79%)
    5 / 47 (10.64%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    6 / 234 (2.56%)
    1 / 22 (4.55%)
         occurrences all number
    1
    6
    0
    1
    6
    1
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    Tremor
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    1 / 22 (4.55%)
         occurrences all number
    4
    1
    0
    1
    7
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 56 (12.50%)
    10 / 47 (21.28%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    31 / 234 (13.25%)
    3 / 22 (13.64%)
         occurrences all number
    8
    12
    2
    1
    36
    3
    Leukopenia
         subjects affected / exposed
    7 / 56 (12.50%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    12 / 234 (5.13%)
    4 / 22 (18.18%)
         occurrences all number
    8
    2
    0
    1
    15
    4
    Neutropenia
         subjects affected / exposed
    19 / 56 (33.93%)
    8 / 47 (17.02%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    38 / 234 (16.24%)
    7 / 22 (31.82%)
         occurrences all number
    41
    17
    0
    2
    92
    13
    Thrombocytopenia
         subjects affected / exposed
    7 / 56 (12.50%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    18 / 234 (7.69%)
    1 / 22 (4.55%)
         occurrences all number
    8
    2
    0
    0
    19
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear congestion
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    1
    2
    0
    Chorioretinopathy
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dry eye
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    1
    8
    0
    Pterygium
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    3 / 7 (42.86%)
    4 / 234 (1.71%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    4
    4
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    22 / 234 (9.40%)
    1 / 22 (4.55%)
         occurrences all number
    4
    1
    0
    2
    26
    1
    Abdominal pain upper
         subjects affected / exposed
    6 / 56 (10.71%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    9 / 234 (3.85%)
    1 / 22 (4.55%)
         occurrences all number
    8
    1
    0
    1
    9
    1
    Constipation
         subjects affected / exposed
    7 / 56 (12.50%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    14 / 234 (5.98%)
    3 / 22 (13.64%)
         occurrences all number
    7
    3
    0
    2
    14
    4
    Diarrhoea
         subjects affected / exposed
    16 / 56 (28.57%)
    10 / 47 (21.28%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    67 / 234 (28.63%)
    10 / 22 (45.45%)
         occurrences all number
    18
    15
    2
    4
    92
    13
    Nausea
         subjects affected / exposed
    12 / 56 (21.43%)
    16 / 47 (34.04%)
    2 / 6 (33.33%)
    2 / 7 (28.57%)
    67 / 234 (28.63%)
    5 / 22 (22.73%)
         occurrences all number
    17
    19
    2
    4
    88
    6
    Vomiting
         subjects affected / exposed
    13 / 56 (23.21%)
    9 / 47 (19.15%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    46 / 234 (19.66%)
    2 / 22 (9.09%)
         occurrences all number
    16
    10
    1
    2
    69
    3
    Abdominal pain lower
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    1
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    10 / 234 (4.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    1
    11
    0
    Odynophagia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    1
    9
    0
    Appendix disorder
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cholestasis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Nail disorder
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    3 / 234 (1.28%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    0
    4
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 56 (5.36%)
    7 / 47 (14.89%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    26 / 234 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    3
    9
    0
    0
    33
    1
    Dysuria
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 47 (8.51%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    6 / 234 (2.56%)
    1 / 22 (4.55%)
         occurrences all number
    2
    4
    0
    0
    7
    1
    Micturition urgency
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    0
    2
    0
    Pollakiuria
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    2
    4
    0
    Proteinuria
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 234 (0.85%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    1
    0
    2
    2
    Renal failure
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    3 / 234 (1.28%)
    2 / 22 (9.09%)
         occurrences all number
    1
    1
    1
    2
    3
    2
    Renal impairment
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences all number
    0
    4
    0
    0
    1
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 234 (0.43%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Thyroiditis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    16 / 234 (6.84%)
    0 / 22 (0.00%)
         occurrences all number
    3
    3
    0
    0
    17
    0
    Pain in extremity
         subjects affected / exposed
    6 / 56 (10.71%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    8 / 234 (3.42%)
    0 / 22 (0.00%)
         occurrences all number
    6
    1
    0
    0
    8
    0
    Muscle spasms
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences all number
    1
    3
    0
    1
    7
    0
    Myalgia
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    3 / 234 (1.28%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    1
    3
    0
    Back pain
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    17 / 234 (7.26%)
    1 / 22 (4.55%)
         occurrences all number
    2
    2
    0
    0
    22
    1
    Osteopenia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Cytomegalovirus viraemia
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 47 (6.38%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    32 / 234 (13.68%)
    0 / 22 (0.00%)
         occurrences all number
    5
    3
    0
    2
    33
    0
    BK virus infection
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    1
    8
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    25 / 234 (10.68%)
    0 / 22 (0.00%)
         occurrences all number
    5
    2
    0
    0
    30
    0
    Influenza
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 234 (0.43%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    13 / 234 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    4
    1
    0
    1
    16
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 47 (8.51%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    12 / 234 (5.13%)
    0 / 22 (0.00%)
         occurrences all number
    4
    4
    0
    0
    13
    0
    Cytomegalovirus infection
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    13 / 234 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    15
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    12 / 234 (5.13%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    16
    0
    Oral candidiasis
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    7 / 234 (2.99%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    0
    0
    8
    1
    Oral herpes
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    9 / 234 (3.85%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    10
    0
    Pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    12 / 234 (5.13%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    12
    0
    Systemic bacterial infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 47 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 47 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 234 (0.85%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    1
    6
    0
    Rhinovirus infection
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    7 / 234 (2.99%)
    3 / 22 (13.64%)
         occurrences all number
    2
    1
    0
    0
    9
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    7 / 56 (12.50%)
    4 / 47 (8.51%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    23 / 234 (9.83%)
    3 / 22 (13.64%)
         occurrences all number
    7
    4
    1
    1
    25
    3
    Hypokalaemia
         subjects affected / exposed
    3 / 56 (5.36%)
    8 / 47 (17.02%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    13 / 234 (5.56%)
    2 / 22 (9.09%)
         occurrences all number
    4
    12
    0
    1
    16
    2
    Hypomagnesaemia
         subjects affected / exposed
    5 / 56 (8.93%)
    9 / 47 (19.15%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    14 / 234 (5.98%)
    4 / 22 (18.18%)
         occurrences all number
    7
    10
    1
    0
    17
    4
    Hypocalcaemia
         subjects affected / exposed
    2 / 56 (3.57%)
    5 / 47 (10.64%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 234 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    5
    0
    0
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    3 / 56 (5.36%)
    6 / 47 (12.77%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 234 (1.71%)
    2 / 22 (9.09%)
         occurrences all number
    3
    10
    0
    0
    4
    2
    Fluid overload
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    4 / 234 (1.71%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    1
    4
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 47 (2.13%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    7 / 234 (2.99%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    1
    7
    0
    Hyperkalaemia
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 47 (4.26%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    10 / 234 (4.27%)
    1 / 22 (4.55%)
         occurrences all number
    3
    3
    0
    0
    11
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2016
    Protocol Amendment 1: Removal of the restriction to utilize only a single commercially available anti-CMV treatment for 8 weeks of the study for the subjects in the IAT arm. Subjects could also continue on prior therapy if this was the treatment option selected by the investigator. Addition of assessment of “invasive bacterial and fungal infection” to the list of safety endpoints since it was one of the AESIs in the study population. Update to the table for prior medications/procedures/diagnostic interventions.
    01 Dec 2016
    Protocol Amendment 2: Modification of Inclusion Criterion 10 to only allow enrollment of subjects who were able to swallow tablets. Inclusion of cutoff levels for CMV DNA concentration in whole blood for evaluating eligibility at screening. Emphasis on potent inducers of cytochrome P450 (CYP) 3A4 and/or P-gp and caution for concomitant use of potent inhibitors of CYP 3A4, in alignment with the guidance to the investigators provided in the maribavir Investigator Brochure (IB). Caution and recommendation for careful monitoring of concentration levels of concomitant medications that were substrates of CYP 2C19 and P-gp both after initiation of maribavir (when substrate levels may increase) and after discontinuation of maribavir (when substrate levels may decrease), in alignment with the guidance to the investigators provided in the maribavir IB. Specified that since intolerance to assigned treatment alone did not qualify a subject for the rescue arm, such subjects would not be considered nonresponders for the purpose of primary analysis. The same would be applicable for subjects that might be discontinued from maribavir due to intolerance. Creation of a list of definitions relevant for analyses for easy access and convenience.
    01 Mar 2017
    Protocol Amendment 3: Modified primary, key secondary, and secondary objectives and corresponding endpoints to include subjects who had discontinued study treatment early and met the criteria of confirmed CMV viremia clearance as responders in the primary efficacy analysis. Added an intensive PK sampling schedule at Visit 3/Week 1 for adolescent subjects (>=12 to <18 years of age). Modified Inclusion Criterion 5 to indicate that the investigator was to be willing to treat the subject with at least 1 of the available anti-CMV drugs. Note: Combination therapy with foscarnet and cidofovir were not permitted in the IAT arm due to the potential for serious nephrotoxicity. Clarified Inclusion Criterion 9 to indicate that urine-based pregnancy tests may have been performed per institutional requirements (in addition to protocol-required serum β-HCG testing); however, they were not sufficient for eligibility determination. Modified Inclusion Criterion 10 to allow subjects the option to receive tablets crushed and/or dispersed in water via a nasogastric or orogastric tube. Clarified in Exclusion Criterion 13 that subjects who had received an unapproved agent or device within 30 days before initiation of study treatment would not be eligible.
    26 Mar 2018
    Protocol Amendment 4: Modified AE collection period to indicate that collection of nonserious AEs that were not related to study-assigned treatment would be restricted to 30 days after the last dose of study-assigned treatment. Amended Exclusion Criterion 6 regarding subjects who had tissue-invasive CMV disease with CNS involvement to indicate that such CNS involvement includes the retina (example, CMV retinitis). Modified the reporting requirements for prior therapeutic or diagnostic interventions performed prior to study enrollment. Clarified procedure requirements for subjects moving from investigator-assigned treatment to rescue arm to indicate that procedures did not need to be repeated when the end-of-treatment visit was performed on the same day as rescue arm entry. Clarified that study treatment could be interrupted for up to 7 consecutive days, or up to 2 study treatment interruptions for a total of up to 7 days. Clarified language regarding sample size calculation, removing anticipated treatment discontinuation rate for foscarnet-treated subjects. Clarified restrictions regarding re-screening of subjects who had previously screen failed. Limited hepatitis testing requirements at screening to antibody testing. Added GVHD assessment criteria forms from cited publications in the appendices. Added letermovir to list of prohibited medications during study, and washout instructions for letermovir use prior to study entry.
    11 Jul 2018
    Protocol Amendment 5: Added a study visit at Day 4 (+/-1) for subjects who were taking a narrow therapeutic index immunosuppressive agent (that is, tacrolimus, cyclosporine, everolimus, sirolimus) at baseline to align the protocol with a recent recommendation from the DMC. Added a visit for subjects not taking a narrow therapeutic index immunosuppressive agent at baseline who began therapy during the course of the treatment period (4 days after starting the immunosuppressive agent), and subjects in the IAT arm who entered the maribavir rescue arm (4 days after starting maribavir) to align the protocol with a recent recommendation from the DMC. Updated definition of symptomatic CMV infection to include both tissue-invasive CMV disease and CMV syndrome throughout the protocol.
    07 Dec 2018
    Protocol Amendment 6: Specified that any subject not tested for HIV within 3 months prior to screening had to be tested during screening by a local laboratory and must have a negative HIV test result available before randomization. Removed Hematopoietic Cell Transplant Comorbidity Index from assessments, and deleted corresponding appendix describing the tool. Specified KPS and Lansky scales were retained as the only assessment tools for evaluation of comorbidity status. Reduced minimum washout period prior to the first dose of study treatment for letermovir from 14 days to 3 days. For subjects who failed to attain CMV viremia clearance, a Visit 18/Week 20 (previously only Visit 16/Week 16) CMV DNA assessment result above the predefined cut off to necessitate CMV genotyping was added. Identified specific dated Summary of Medicinal Product Characteristics as reference safety information for investigator-assigned treatments. Removed requirement of duplicate SAE and pregnancy reporting to PPD/CRO and Medical Monitors, removed corresponding erroneous contacts, updated name of Shire Global Drug Safety Department, and removed individual names of medical contacts at PPD. Clarified that a product quality complaint from any site had to be directed to a single central e-mail address.

    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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