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    Clinical Trial Results:
    A Multicenter, Open-label, Randomized, Two Arm Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients

    Summary
    EudraCT number
    		 2015-003528-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Mar 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2016
    First version publication date
    19 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCHI621ADE04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00149890
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Mar 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the effect of an immunosuppressive therapy administered with intraoperative versus without intraoperative steroids in combination with Simulect®, Sandimmun®/ Sandimmun® Optoral and steroids, as measured by the incidence of at least one biopsy proven acute rejection episode, graft loss, or death within the first three months post-transplantation in pediatric de novo liver transplant recipients.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Mar 2004
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 77
    Worldwide total number of subjects
    77
    EEA total number of subjects
    77
    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)
    45
    Children (2-11 years)
    23
    Adolescents (12-17 years)
    9
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 It was initially planned to include a total of 80 patients. A total of 77 patients were screened and treated with study medication .

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 With Intraoperative Steroids
    Arm description
    		 Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Basiliximab
    Investigational medicinal product code
    Other name
    Simulect®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight <35 kg) or 20 mg (body weight ≥35 kg) strength.

    Investigational medicinal product name
    Cyclosporine/cyclosporine microemulsion
    Investigational medicinal product code
    Other name
    Sandimmun®/Sandimmun® Optoral
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m^2/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels.

    Investigational medicinal product name
    Steroid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous prednisolone (loading dose: 300 mg/m^2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m^2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m^2/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m^2/day orally (until end of month 2), to 2.5 mg/m^2/day orally (until end of month 3) and to 1 mg/m^2/day orally (until end of month 6).

    Arm title
    		 Without Intraoperative Steroids
    Arm description
    		 No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Basiliximab
    Investigational medicinal product code
    Other name
    Simulect®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight <35 kg) or 20 mg (body weight ≥35 kg) strength.

    Investigational medicinal product name
    Cyclosporine/cyclosporine microemulsion
    Investigational medicinal product code
    Other name
    Sandimmun®/Sandimmun® Optoral
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m^2/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels.

    Investigational medicinal product name
    Steroid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous prednisolone (loading dose: 300 mg/m^2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m^2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m^2/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m^2/day orally (until end of month 2), to 2.5 mg/m^2/day orally (until end of month 3) and to 1 mg/m^2/day orally (until end of month 6).

    Number of subjects in period 1
    		With Intraoperative Steroids Without Intraoperative Steroids
    Started
    39
    38
    Completed
    26
    20
    Not completed
    13
    18
         Protocol Violavtion
    1
    -
         Graft loss
    2
    1
         Adverse event, non-fatal
    1
    8
         Lost to follow-up
    1
    -
         Lack of efficacy
    8
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    With Intraoperative Steroids
    Reporting group description
    		 Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.

    Reporting group title
    Without Intraoperative Steroids
    Reporting group description
    		 No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.

    Reporting group values
    		 With Intraoperative Steroids Without Intraoperative Steroids Total
    Number of subjects
    		 39 38 77
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 21 24 45
        Children (2-11 years)
    		 15 8 23
        Adolescents (12-17 years)
    		 3 6 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.08 ( 4.09 ) 3.71 ( 5.36 ) -
    Gender categorical
    Units: Subjects
        Female
    		 21 19 40
        Male
    		 18 19 37

    End points

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    End points reporting groups
    Reporting group title
    With Intraoperative Steroids
    Reporting group description
    		 Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.

    Reporting group title
    Without Intraoperative Steroids
    Reporting group description
    		 No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.

    Primary: Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation

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    End point title
    		 Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation [1]
    End point description
    Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.
    End point type
    Primary
    End point timeframe
    3 months after treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis provided for Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation .
    End point values
    		 With Intraoperative Steroids Without Intraoperative Steroids
    Number of subjects analysed
    39 [2]
    38 [3]
    Units: Participants
    number (not applicable)
        Stratum age < 2 years (N=21, 24)
    8
    15
        Stratum age 2-16 years (N=18, 14)
    14
    11
        Total (N= 39, 38)
    22
    26
    Notes
    [2] - safety/Intent to Treat (ITT) population
    [3] - safety/Intent to Treat (ITT) population
    No statistical analyses for this end point

    Secondary: Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months

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    End point title
    		 Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months
    End point description
    At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 With Intraoperative Steroids Without Intraoperative Steroids
    Number of subjects analysed
    39 [4]
    38 [5]
    Units: Participants
        number (not applicable)
    20
    26
    Notes
    [4] - safety/Intent to Treat (ITT) population
    [5] - safety/Intent to Treat (ITT) population
    No statistical analyses for this end point

    Secondary: Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months

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    End point title
    		 Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months
    End point description
    To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months.
    End point type
    Secondary
    End point timeframe
    3 and 6 months
    End point values
    		 With Intraoperative Steroids Without Intraoperative Steroids
    Number of subjects analysed
    39 [6]
    38 [7]
    Units: Participants
    number (not applicable)
        Within 3 months post treatment
    2
    2
        Within 6 months post treatment
    2
    2
    Notes
    [6] - safety/Intent to Treat (ITT) population
    [7] - safety/Intent to Treat (ITT) population
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation

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    End point title
    		 Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation
    End point description
    Graft loss is defined as being listed for a re-transplantation.
    End point type
    Secondary
    End point timeframe
    3 months and 6 months
    End point values
    		 With Intraoperative Steroids Without Intraoperative Steroids
    Number of subjects analysed
    39 [8]
    38 [9]
    Units: Percentage of participants
    number (not applicable)
        Death within 3 months post treatment
    0
    2.6
        Death within 6 months post treatment
    0
    2.6
        Graft Loss within 3 months post treatment
    5.1
    2.6
        Graft Loss within 6 months post treatment
    5.1
    5.3
    Notes
    [8] - safety/Intent to Treat (ITT) population
    [9] - safety/Intent to Treat (ITT) population
    No statistical analyses for this end point

    Secondary: Number of Participants With Bacterial, Viral and Fungal Infections During Six Months

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    End point title
    		 Number of Participants With Bacterial, Viral and Fungal Infections During Six Months
    End point description
    To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 With Intraoperative Steroids Without Intraoperative Steroids
    Number of subjects analysed
    39 [10]
    38 [11]
    Units: Participants
    number (not applicable)
        Fungal
    16
    16
        Viral
    15
    14
        Bacterial
    10
    18
    Notes
    [10] - Safety Population
    [11] - Safety Population
    No statistical analyses for this end point

    Secondary: Time of Onset of a First Biopsy Proven Acute Rejection

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    End point title
    		 Time of Onset of a First Biopsy Proven Acute Rejection
    End point description
    Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 With Intraoperative Steroids Without Intraoperative Steroids
    Number of subjects analysed
    39 [12]
    38 [13]
    Units: months
        median (confidence interval 95%)
    1.93 (0.99 to 9.99)
    0.75 (0.4 to 1.31)
    Notes
    [12] - safety/ITT population 0.99/9.99 = Upper bound of the Confidence Interval was not attained
    [13] - safety/Intent to Treat (ITT) population
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Treatment Failure Within Three and Six Months

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    End point title
    		 Percentage of Participants With Treatment Failure Within Three and Six Months
    End point description
    To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months.
    End point type
    Secondary
    End point timeframe
    3 and 6 months
    End point values
    		 With Intraoperative Steroids Without Intraoperative Steroids
    Number of subjects analysed
    39 [14]
    38 [15]
    Units: Percentage of participants
    number (confidence interval 95%)
        3 month: Age < 2 years (N= 21, 24)
    0 (0 to 16.11)
    4.17 (0.11 to 21.12)
        3 month: Age 2-16 years (N= 18, 14)
    11.11 (1.38 to 34.71)
    7.14 (0.18 to 33.87)
        3 Month: Total
    5.13 (0.63 to 17.32)
    5.26 (0.64 to 17.75)
        6 month: Age < 2 years (N= 21, 24)
    0 (0 to 16.11)
    4.17 (0.11 to 21.12)
        6 month: Age 2-16 years (N= 18, 14)
    11.11 (1.38 to 34.71)
    7.14 (0.18 to 33.87)
        6 Month: Total
    5.13 (0.63 to 17.32)
    5.26 (0.64 to 17.75)
    Notes
    [14] - Intention to treat population
    [15] - Intention to treat population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    With intraoperative steroids
    Reporting group description
    		 With intraoperative steroids

    Reporting group title
    Without intraoperative steroids
    Reporting group description
    		 Without intraoperative steroids

    Serious adverse events
    		 With intraoperative steroids Without intraoperative steroids
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 39 (46.15%)
    23 / 38 (60.53%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Histiocytosis haematophagic
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inferior vena caval occlusion
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reperfusion injury
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device occlusion
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchomalacia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chylothorax
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic rupture
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatopulmonary syndrome
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachypnoea
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Epstein-barr virus antibody positive
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunosuppressant drug level decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary anastomosis complication
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted liver
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft complication
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft loss
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic haematoma
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic rupture
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    0 / 39 (0.00%)
    5 / 38 (13.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal fistula
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biloma
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic hepatic failure
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemobilia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic artery thrombosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic necrosis
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic vein thrombosis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein stenosis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    5 / 39 (12.82%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-barr viraemia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 38 (7.89%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis astroviral
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 With intraoperative steroids Without intraoperative steroids
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 39 (100.00%)
    38 / 38 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    29 / 39 (74.36%)
    27 / 38 (71.05%)
         occurrences all number
    35
    35
    Hypotension
         subjects affected / exposed
    7 / 39 (17.95%)
    8 / 38 (21.05%)
         occurrences all number
    7
    12
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Vena cava thrombosis
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Drug withdrawal syndrome
         subjects affected / exposed
    7 / 39 (17.95%)
    7 / 38 (18.42%)
         occurrences all number
    7
    10
    Obstruction
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Oedema
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Pain
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 38 (7.89%)
         occurrences all number
    2
    3
    Pyrexia
         subjects affected / exposed
    19 / 39 (48.72%)
    25 / 38 (65.79%)
         occurrences all number
    31
    44
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    10 / 39 (25.64%)
    12 / 38 (31.58%)
         occurrences all number
    12
    14
    Chylothorax
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Epistaxis
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 38 (7.89%)
         occurrences all number
    2
    3
    Obstructive airways disorder
         subjects affected / exposed
    11 / 39 (28.21%)
    14 / 38 (36.84%)
         occurrences all number
    11
    16
    Pleural effusion
         subjects affected / exposed
    18 / 39 (46.15%)
    24 / 38 (63.16%)
         occurrences all number
    20
    32
    Pneumothorax
         subjects affected / exposed
    3 / 39 (7.69%)
    4 / 38 (10.53%)
         occurrences all number
    4
    4
    Respiratory failure
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Tachypnoea
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 39 (10.26%)
    4 / 38 (10.53%)
         occurrences all number
    4
    4
    Restlessness
         subjects affected / exposed
    10 / 39 (25.64%)
    14 / 38 (36.84%)
         occurrences all number
    10
    15
    Investigations
    Antithrombin iii decreased
         subjects affected / exposed
    16 / 39 (41.03%)
    16 / 38 (42.11%)
         occurrences all number
    16
    16
    Blood magnesium decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Blood urea increased
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    C-reactive protein increased
         subjects affected / exposed
    3 / 39 (7.69%)
    7 / 38 (18.42%)
         occurrences all number
    4
    8
    Drug level decreased
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 38 (7.89%)
         occurrences all number
    0
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Immunoglobulins decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
         occurrences all number
    1
    2
    Red blood cell count decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Transaminases increased
         subjects affected / exposed
    5 / 39 (12.82%)
    3 / 38 (7.89%)
         occurrences all number
    5
    3
    Injury, poisoning and procedural complications
    Complications of transplanted liver
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Hepatic haematoma
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Post procedural bile leak
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Procedural pain
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 38 (7.89%)
         occurrences all number
    2
    3
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Bradycardia
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Tachycardia
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    17 / 39 (43.59%)
    17 / 38 (44.74%)
         occurrences all number
    26
    24
    Coagulopathy
         subjects affected / exposed
    2 / 39 (5.13%)
    6 / 38 (15.79%)
         occurrences all number
    2
    8
    Iron deficiency anaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 38 (2.63%)
         occurrences all number
    3
    1
    Leukocytosis
         subjects affected / exposed
    2 / 39 (5.13%)
    6 / 38 (15.79%)
         occurrences all number
    3
    6
    Leukopenia
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 38 (10.53%)
         occurrences all number
    1
    5
    Thrombocytopenia
         subjects affected / exposed
    10 / 39 (25.64%)
    11 / 38 (28.95%)
         occurrences all number
    12
    14
    Thrombocytosis
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 39 (20.51%)
    14 / 38 (36.84%)
         occurrences all number
    9
    21
    Ascites
         subjects affected / exposed
    12 / 39 (30.77%)
    12 / 38 (31.58%)
         occurrences all number
    13
    15
    Constipation
         subjects affected / exposed
    15 / 39 (38.46%)
    17 / 38 (44.74%)
         occurrences all number
    18
    22
    Diarrhoea
         subjects affected / exposed
    6 / 39 (15.38%)
    3 / 38 (7.89%)
         occurrences all number
    7
    3
    Flatulence
         subjects affected / exposed
    20 / 39 (51.28%)
    16 / 38 (42.11%)
         occurrences all number
    22
    18
    Gingival hyperplasia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    6 / 39 (15.38%)
    2 / 38 (5.26%)
         occurrences all number
    6
    4
    Peritonitis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
         occurrences all number
    1
    2
    Vomiting
         subjects affected / exposed
    10 / 39 (25.64%)
    15 / 38 (39.47%)
         occurrences all number
    14
    22
    Hepatobiliary disorders
    Bile duct necrosis
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Bile duct obstruction
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Cholangitis
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Cholestasis
         subjects affected / exposed
    1 / 39 (2.56%)
    7 / 38 (18.42%)
         occurrences all number
    1
    8
    Hepatic ischaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Pneumobilia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 38 (2.63%)
         occurrences all number
    3
    1
    Portal vein stenosis
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Hirsutism
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Petechiae
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 38 (7.89%)
         occurrences all number
    3
    3
    Renal and urinary disorders
    Oliguria
         subjects affected / exposed
    2 / 39 (5.13%)
    5 / 38 (13.16%)
         occurrences all number
    3
    6
    Renal failure
         subjects affected / exposed
    3 / 39 (7.69%)
    6 / 38 (15.79%)
         occurrences all number
    3
    6
    Renal failure chronic
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 38 (5.26%)
         occurrences all number
    2
    2
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Hypothyroidism
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    3
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 38 (7.89%)
         occurrences all number
    2
    3
    Adenovirus infection
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Bacterial infection
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Bronchitis
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
         occurrences all number
    4
    2
    Candidiasis
         subjects affected / exposed
    7 / 39 (17.95%)
    11 / 38 (28.95%)
         occurrences all number
    7
    12
    Cytomegalovirus infection
         subjects affected / exposed
    6 / 39 (15.38%)
    6 / 38 (15.79%)
         occurrences all number
    6
    6
    Enterococcal infection
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
         occurrences all number
    1
    2
    Epstein-barr virus infection
         subjects affected / exposed
    7 / 39 (17.95%)
    9 / 38 (23.68%)
         occurrences all number
    8
    9
    Fungal infection
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    4 / 39 (10.26%)
    2 / 38 (5.26%)
         occurrences all number
    4
    3
    Human herpesvirus 6 infection
         subjects affected / exposed
    2 / 39 (5.13%)
    4 / 38 (10.53%)
         occurrences all number
    2
    4
    Infection
         subjects affected / exposed
    4 / 39 (10.26%)
    5 / 38 (13.16%)
         occurrences all number
    4
    5
    Infectious disease carrier
         subjects affected / exposed
    6 / 39 (15.38%)
    4 / 38 (10.53%)
         occurrences all number
    6
    4
    Oral herpes
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Pneumonia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 38 (10.53%)
         occurrences all number
    1
    5
    Rhinitis
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 38 (7.89%)
         occurrences all number
    3
    3
    Sepsis
         subjects affected / exposed
    3 / 39 (7.69%)
    4 / 38 (10.53%)
         occurrences all number
    3
    6
    Staphylococcal infection
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    Wound infection
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    5 / 39 (12.82%)
    6 / 38 (15.79%)
         occurrences all number
    5
    11
    Hyperglycaemia
         subjects affected / exposed
    8 / 39 (20.51%)
    15 / 38 (39.47%)
         occurrences all number
    9
    17
    Hyperkalaemia
         subjects affected / exposed
    8 / 39 (20.51%)
    8 / 38 (21.05%)
         occurrences all number
    13
    11
    Hyperlipidaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Hyperphosphataemia
         subjects affected / exposed
    3 / 39 (7.69%)
    4 / 38 (10.53%)
         occurrences all number
    3
    5
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Hypoalbuminaemia
         subjects affected / exposed
    4 / 39 (10.26%)
    4 / 38 (10.53%)
         occurrences all number
    5
    6
    Hypocalcaemia
         subjects affected / exposed
    8 / 39 (20.51%)
    15 / 38 (39.47%)
         occurrences all number
    9
    23
    Hypoglycaemia
         subjects affected / exposed
    4 / 39 (10.26%)
    2 / 38 (5.26%)
         occurrences all number
    5
    3
    Hypokalaemia
         subjects affected / exposed
    8 / 39 (20.51%)
    13 / 38 (34.21%)
         occurrences all number
    10
    20
    Hypomagnesaemia
         subjects affected / exposed
    21 / 39 (53.85%)
    15 / 38 (39.47%)
         occurrences all number
    25
    19
    Hyponatraemia
         subjects affected / exposed
    6 / 39 (15.38%)
    6 / 38 (15.79%)
         occurrences all number
    6
    7
    Hypophosphataemia
         subjects affected / exposed
    5 / 39 (12.82%)
    4 / 38 (10.53%)
         occurrences all number
    5
    5
    Hypoproteinaemia
         subjects affected / exposed
    10 / 39 (25.64%)
    5 / 38 (13.16%)
         occurrences all number
    10
    6
    Hypovolaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Metabolic acidosis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 38 (5.26%)
         occurrences all number
    1
    4
    Vitamin k deficiency
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2

    More information

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

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

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

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