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    Clinical Trial Results:
    Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - EXTended Criteria Donors (BENEFIT-EXT)

    Summary
    EudraCT number
    		 2004-002974-48
    Trial protocol
    		 GB   HU   AT   BE   SE   DE   CZ   IT   ES   PT  
    Global end of trial date
    30 Sep 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    IM103-027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00114777
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb International Corporation
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the effects of belatacept, relative to cyclosporin A, on the following: 1. Subject and graft survival by 12 months 2. Measured glomerular filtration (GFR) rate <60 mL/min/1.73 m^2 at Month 12 or a decrease in measured GFR ≥ 10 mL/min/1.73 m^2 from Month 3 to Month 12. Assess the long term safety and tolerability of belatacept in subjects who have received a kidney transplant, completed the Short Term (36 months of treatment in the main study) and remain on study therapy for up to an additional 48 months.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 All subjects received induction with basiliximab and a background maintenance immunosuppressive regimen of mycophenolate mofetil and corticosteroids.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Mar 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 48 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 12
    Country: Number of subjects enrolled
    France: 106
    Country: Number of subjects enrolled
    Germany: 49
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 55
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 139
    Country: Number of subjects enrolled
    Argentina: 64
    Country: Number of subjects enrolled
    Austria: 10
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Brazil: 95
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    Chile: 1
    Worldwide total number of subjects
    595
    EEA total number of subjects
    280
    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)
    416
    From 65 to 84 years
    179
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 79 sites; 28 in the United States, 9 in France, 6 in Brazil, 5 each in Germany, Argentina, and Spain, 4 in Canada, 3 in Italy, 2 each in Hungary, Austria, and Poland, 1 each in Belgium, Chile, Czech Republic, Norway, South Africa, Sweden, UK, and Australia.

    Pre-assignment
    Screening details
    		 A total of 595 subjects were enrolled; 578 were randomized: 13 subjects no longer met study criteria; 3 discontinued on sponsor’s discretion; and 1 discontinued due to "other" reason.

    Period 1
    Period 1 title
    Randomization to Month 36
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    During the first 36 months, study drugs (belatacept or cyclosporine A) were administered in an open-label fashion. The assigned dose regimen (MI or LI) of the belatacept-treated subjects was blinded both to the subjects and study personnel up to Month 36.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Belatacept MI (Period 1)
    Arm description
    		 Subjects in more intensive (MI) regimen received belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 36 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belatacept
    Investigational medicinal product code
    BMS-224818
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Belatacept 10-mg/kg intravenous solution over 30 minutes on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for 36 months.

    Arm title
    		 Belatacept LI (Period 1)
    Arm description
    		 Subjects in less intensive (LI) regimenreceived belatacept, 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 36 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belatacept
    Investigational medicinal product code
    BMS-224818
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Belatacept 10-mg/kg intravenous solution for over 30 minutes on n Day 1 and Day 5 during the first week, and then every other week for [4] weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg i.v. every 4 weeks thereafter for 36 months.

    Arm title
    		 Cyclosporin A (Period 1)
    Arm description
    		 Subjects received an initial daily dose of 4 -10 mg/kg cyclosporin A capsules orally, in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 36 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclosporin A
    Investigational medicinal product code
    Other name
    Neoral®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cyclosporine was initially administered at a daily dose of 4-10 mg/kg, orally as capsules. The dose was then adjusted to maintain trough whole blood concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough whole blood concentrations of 100-250 ng/mL for up to 36 months.

    Number of subjects in period 1 [1]
    		Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Started
    184
    175
    184
    Received treatment
    183
    174
    179
    Completed
    109
    114
    100
    Not completed
    75
    61
    84
         Consent withdrawn by subject
    3
    4
    5
         Adverse event, non-fatal
    34
    35
    44
         Poor/non-Compliance
    -
    -
    1
         Death
    10
    4
    3
         Subject no longer meet study criteria
    -
    -
    2
         Other reasons
    9
    3
    12
         Lack of efficacy
    19
    15
    17
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial as of the 595 subjects enrolled only 578 subjects randomized and 543 were transplanted into the study. The 17 subjects which were not randomized for the following reasons: 13 no longer met study criteria, 3 discontinued on sponsor's discretion, and 1 discontinued for "other", a non-specified reason.
    Period 2
    Period 2 title
    Long-Term Extension to Month 84
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The long-term extension was conducted as a fully open-label clinical study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Belatacept MI (Period 2)
    Arm description
    		 Subjects in more intensive (MI) regimen during long term extension continued to receive belatacept at a maintenance dose of 5 mg/kg intravenously every 4 weeks for up to 84 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belatacept
    Investigational medicinal product code
    BMS-224818
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Belatacept 5 mg/kg intravenous solution over 30 minutes every 4 weeks for up to 84 months.

    Arm title
    		 Belatacept LI (Period 2)
    Arm description
    		 Subjects in less intensive (LI) regimen during long term extension continued to receive belatacept at a maintenance dose of 5 mg/kg intravenously every 4 weeks for up to 84 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belatacept
    Investigational medicinal product code
    BMS-224818
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Belatacept 5 mg/kg intravenous solution over 30 minutes every 4 weeks for up to 84 months.

    Arm title
    		 Cyclosporin A (Period 2)
    Arm description
    		 Subjects during the long-term extension continued to receive doses that were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclosporin A
    Investigational medicinal product code
    Other name
    Neoral®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cyclosporine A doses were adjusted to maintain a predefined range of trough whole blood concentrations of 100-250 ng/mL for up to 84 months.

    Number of subjects in period 2 [2]
    		Belatacept MI (Period 2) Belatacept LI (Period 2) Cyclosporin A (Period 2)
    Started
    104
    113
    87
    Completed
    74
    84
    57
    Not completed
    30
    29
    30
         Consent withdrawn by subject
    2
    1
    6
         Adverse event, non-fatal
    15
    14
    7
         Poor/non-Compliance
    1
    1
    3
         Death
    8
    13
    7
         Subject no longer met study criteria
    1
    -
    -
         Other reasons
    2
    -
    3
         Lost to follow-up
    -
    -
    2
         Subject no longer meets study criteria
    -
    -
    1
         Lack of efficacy
    1
    -
    1
    Notes
    [2] - 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 participants chose to enter long-term extension phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Belatacept MI (Period 1)
    Reporting group description
    		 Subjects in more intensive (MI) regimen received belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 36 months.

    Reporting group title
    Belatacept LI (Period 1)
    Reporting group description
    		 Subjects in less intensive (LI) regimenreceived belatacept, 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 36 months.

    Reporting group title
    Cyclosporin A (Period 1)
    Reporting group description
    		 Subjects received an initial daily dose of 4 -10 mg/kg cyclosporin A capsules orally, in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 36 months.

    Reporting group values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1) Total
    Number of subjects
    		 184 175 184 543
    Age categorical
    Units: Subjects
        18 years to 45 years
    		 32 35 34 101
        46 years to 65 years
    		 100 97 108 305
        more than 65 years
    		 52 43 42 137
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.7 ( 12.6 ) 56.1 ( 12.4 ) 55.7 ( 12.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 46 68 179
        Male
    		 119 129 116 364

    End points

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    End points reporting groups
    Reporting group title
    Belatacept MI (Period 1)
    Reporting group description
    		 Subjects in more intensive (MI) regimen received belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 36 months.

    Reporting group title
    Belatacept LI (Period 1)
    Reporting group description
    		 Subjects in less intensive (LI) regimenreceived belatacept, 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 36 months.

    Reporting group title
    Cyclosporin A (Period 1)
    Reporting group description
    		 Subjects received an initial daily dose of 4 -10 mg/kg cyclosporin A capsules orally, in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 36 months.
    Reporting group title
    Belatacept MI (Period 2)
    Reporting group description
    		 Subjects in more intensive (MI) regimen during long term extension continued to receive belatacept at a maintenance dose of 5 mg/kg intravenously every 4 weeks for up to 84 months.

    Reporting group title
    Belatacept LI (Period 2)
    Reporting group description
    		 Subjects in less intensive (LI) regimen during long term extension continued to receive belatacept at a maintenance dose of 5 mg/kg intravenously every 4 weeks for up to 84 months.

    Reporting group title
    Cyclosporin A (Period 2)
    Reporting group description
    		 Subjects during the long-term extension continued to receive doses that were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.

    Subject analysis set title
    Belatacept MI (Periods 1&2)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat (ITT) Population

    Subject analysis set title
    Belatacept LI (Periods 1&2)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    intent-to-treat (ITT) population

    Subject analysis set title
    Cyclosporin A (Periods 1&2)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat (ITT) population

    Primary: Percentage of Subjects Who Survived With a Graft at 12 Months Post-Transplant

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    End point title
    		 Percentage of Subjects Who Survived With a Graft at 12 Months Post-Transplant
    End point description
    Subject and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 µmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis. The analysis was performed in the Intent-to-Treat population which includes all the subjects who are randomized into the study and received a transplant. Patients whose death or graft loss status was missing at Month 12 were imputed to have experienced death or graft loss if one or more of the criteria pre-specified in the statistical analysis plan for the study were met.
    End point type
    Primary
    End point timeframe
    Month 12 post-transplant
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of Subjects
        number (confidence interval 95%)
    85.9 (80.8 to 90.9)
    88 (83.2 to 92.8)
    84.8 (79.6 to 90)
    Statistical analysis title
    		 Subject and Graft Survival of Belatacept MI
    Statistical analysis description
    The treatment differences between each belatacept MI treatment group and cyclosporine group was tested at the 0.027 significance level for subject and graft survival (based on 10% non-inferiority margin).
    Comparison groups
    Belatacept MI (Period 1) v Cyclosporin A (Period 1)
    Number of subjects included in analysis
    368
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Treatment Difference
    Point estimate
    1.1
    Confidence interval
         level
    		 97.3%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 9.4
    Statistical analysis title
    		 Subject and Graft Survival of Belatacept LI
    Statistical analysis description
    The treatment differences between each belatacept LI treatment group and cyclosporine group was tested at the 0.027 significance level for subject and graft survival (based on 10% non-inferiority margin).
    Comparison groups
    Cyclosporin A (Period 1) v Belatacept LI (Period 1)
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Treatment Difference
    Point estimate
    3.2
    Confidence interval
         level
    		 97.3%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 11.4

    Primary: Percentage of Subjects with a Measured Glomerular Filtration Rate (GFR) <60 mL/min per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/min per 1.73 m^2 from Month 3 to Month 12

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    End point title
    		 Percentage of Subjects with a Measured Glomerular Filtration Rate (GFR) <60 mL/min per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/min per 1.73 m^2 from Month 3 to Month 12
    End point description
    GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure. The analysis was performed in the Intent-to-Treat population. Missing measured GFR assessments were imputed as having a GFR of zero.
    End point type
    Primary
    End point timeframe
    From Month 3 to Month 12
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of subjects
    number (not applicable)
        Measured GFR <60 mL/min/1.73 m^2 at month 12
    55.7
    62.1
    67.4
        GFR ↓ of ≥ 10 mL/min/1.73 m^2 from months 3-12
    17.6
    27.2
    24.7
    Statistical analysis title
    		 Measured GFR of Belatacept MI
    Statistical analysis description
    A continuity-corrected chi-square test (at the significance level 0.027) was performed to assess the effect of each belatacept regimen on renal function compared with CsA. 2-sided 97.3% CIs were generated for the difference in the percentage of subjects meeting the composite renal function endpoint between belatacept MI regimen and cyclosporine.
    Comparison groups
    Belatacept MI (Period 1) v Cyclosporin A (Period 1)
    Number of subjects included in analysis
    368
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0018
    Method
    		 Chi-squared
    Parameter type
    		 Percentage Difference
    Point estimate
    -14.4
    Confidence interval
         level
    		 97.3%
         sides
    2-sided
         lower limit
    		 -24
         upper limit
    		 -4.7
    Statistical analysis title
    		 Measured GFR of Belatacept LI
    Statistical analysis description
    A continuity-corrected chi-square test (at the significance level 0.027) was performed to assess the effect of each belatacept regimen on renal function compared with CsA. 2-sided 97.3% CIs were generated for the difference in the Percentage of subjects meeting the composite renal function endpoint between belatacept LI regimen and cyclosporine.
    Comparison groups
    Cyclosporin A (Period 1) v Belatacept LI (Period 1)
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0616
    Method
    		 Chi-squared
    Parameter type
    		 Percentage Difference
    Point estimate
    -8.5
    Confidence interval
         level
    		 97.3%
         sides
    2-sided
         lower limit
    		 -18
         upper limit
    		 0.9

    Secondary: Measured Glomerular Filtration Rate (GFR) by Month 12 and 24

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    End point title
    		 Measured Glomerular Filtration Rate (GFR) by Month 12 and 24
    End point description
    GFR was assessed using a true measure of glomerular filtration via a non-radiolabeled iothalamate clearance test using a validated procedure. The analysis was performed in the Intent-to-Treat population. Missing measured GFR assessments were imputed to a GFR of zero. Here, ‘n’ signifies the number of evaluable subjects for the reporting arm at the given time point.
    End point type
    Secondary
    End point timeframe
    Month 12, and 24
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: mL/min/1.73 m^2
    arithmetic mean (standard deviation)
        Month 12
    52.1 ( 21.9 )
    49.5 ( 25.4 )
    45.2 ( 21.1 )
        Month 24
    51.5 ( 22.9 )
    49.7 ( 23.67 )
    45 ( 27.18 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Chronic Allograft Nephropathy (CAN) at Month 12

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    End point title
    		 Percentage of Subjects with Chronic Allograft Nephropathy (CAN) at Month 12
    End point description
    Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Subjects were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Subject had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m^2. All other subjects with missing 12 month biopsy were considered having no CAN observed at 12 months. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of Subjects
        number (confidence interval 95%)
    44.8 (37.6 to 52)
    46 (38.6 to 53.4)
    51.6 (44.4 to 58.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Survived With a Graft at 24 and 36 Months Post-Transplant

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    End point title
    		 Percentage of Subjects Who Survived With a Graft at 24 and 36 Months Post-Transplant
    End point description
    Subject and graft survival at 24 and 36 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 µmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis. The analysis was performed in the Intent-to-Treat population which includes all the subjects who were randomized into the study and received a transplant.
    End point type
    Secondary
    End point timeframe
    Month 24 and 36 post-transplant
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of subjects
    number (confidence interval 95%)
        Month 24
    82.6 (77.1 to 88.1)
    84 (78.6 to 89.4)
    82.6 (77.1 to 88.1)
        Month 36
    80.4 (74.7 to 86.2)
    82.3 (76.6 to 87.9)
    79.9 (74.1 to 85.7)
    No statistical analyses for this end point

    Secondary: Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months

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    End point title
    		 Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
    End point description
    GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure. The analysis was performed in the Intent-to-Treat population. Missing measured GFR assessments were imputed as a GFR of zero. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 6, 12, 24, 36 and 84
    End point values
    		 Belatacept MI (Periods 1&2) Belatacept LI (Periods 1&2) Cyclosporin A (Periods 1&2)
    Number of subjects analysed
    184
    175
    184
    Units: mL/min/1.73 m^2
    arithmetic mean (standard deviation)
        Month 6 (n = 161,152,153)
    43.6 ( 21.67 )
    43.4 ( 18.57 )
    35.5 ( 20.51 )
        Month 12 (n = 159,154,154)
    44.4 ( 22.78 )
    44.8 ( 21.57 )
    36.5 ( 21.08 )
        Month 24 (n = 152,158,154)
    44.4 ( 26.72 )
    42.8 ( 24.07 )
    34.9 ( 21.59 )
        Month 36 (n = 152,154,143)
    42.7 ( 27.59 )
    42.2 ( 25.2 )
    31.5 ( 22.13 )
        Month 84 (n = 69,79,51)
    57.6 ( 18.58 )
    59.1 ( 18.85 )
    44.6 ( 17.37 )
    No statistical analyses for this end point

    Secondary: Change in Calculated GFR from Month 3 to 12, 24, 36 and 84

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    End point title
    		 Change in Calculated GFR from Month 3 to 12, 24, 36 and 84
    End point description
    GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure. The analysis was performed in the Intent-to-Treat population. Missing measured GFR assessments were imputed to a GFR of zero. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36 and 84
    End point values
    		 Belatacept MI (Periods 1&2) Belatacept LI (Periods 1&2) Cyclosporin A (Periods 1&2)
    Number of subjects analysed
    184
    175
    184
    Units: mL/min/1.73 m^2
    arithmetic mean (standard deviation)
        Month 12 (n = 159,154,154)
    -0.7 ( 17.96 )
    -0.6 ( 15.39 )
    -1.1 ( 12.48 )
        Month 24 (n = 146,154,149)
    -1.4 ( 17.68 )
    -1.6 ( 18.7 )
    -3.6 ( 15.37 )
        Month 36 (n = 146,150,139)
    -2.9 ( 23.7 )
    -2.1 ( 20.92 )
    -6.1 ( 17.39 )
        Month 84 (n = 67,76,49)
    7.5 ( 17.48 )
    10.4 ( 17.54 )
    -4 ( 17.17 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months

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    End point title
    		 Number of Subjects with Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
    End point description
    Subjects were determined to have hypertension at a particular time point if standardized SBP ≥ 130 mm Hg or standardized DBP ≥ 80 mm Hg or subject had received an antihypertensive medication(s) for hypertension. The analysis was performed in the Intent-to-Treat population. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Number of subjects
        1-2 Medications (Month 12) (n= 184,175,184)
    82
    79
    76
        ≥ 3 Medications (Month 12) (n= 184,175,184)
    76
    66
    93
        1-2 Medications (Month 24) (n= 177,170,179)
    80
    79
    71
        ≥ 3 Medications (Month 24) (n= 177,170,179)
    78
    65
    89
        1-2 Medications (Month 36) (n= 151,145,143)
    65
    67
    51
        ≥ 3 Medications (Month 36) (n= 151,145,143)
    70
    60
    79
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Used Anti-Aypertensive Medications to Control Hypertension at Month 12, 24 and 36

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    End point title
    		 Percentage of Subjects Who Used Anti-Aypertensive Medications to Control Hypertension at Month 12, 24 and 36
    End point description
    Subjects were determined to have hypertension at a particular time point if standardized SBP ≥ 130 mm Hg or standardized DBP ≥ 80 mm Hg or subject had received an antihypertensive medication(s) for hypertension. The analysis was performed in the Intent-to-Treat population. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of subject
    number (confidence interval 95%)
        Month 12 (n = 184,175,184)
    87 (82.09 to 91.82)
    83.4 (77.92 to 88.94)
    87 (82.09 to 91.82)
        Month 24 (n = 177,170,179)
    89.3 (84.71 to 93.83)
    84.7 (79.3 to 90.12)
    89.4 (84.87 to 93.9)
        Month 36 (n = 151,145,143)
    89.4 (84.49 to 94.31)
    87.6 (82.22 to 92.25)
    90.9 (86.2 to 95.62)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months

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    End point title
    		 Percentage of Subjects with New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months
    End point description
    NODM was defined as subject who did not have diabetes prior to randomization. Subjects were determined for NODM if the subject received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L). The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of subjects
    number (not applicable)
        12 Month
    2.3
    5.1
    9.3
        24 Month
    3
    7.4
    9.3
        36 Month
    5.3
    9.6
    9.3
    No statistical analyses for this end point

    Secondary: Systolic and Diastolic Blood Pressure at 12, 24 and 36 Months

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    End point title
    		 Systolic and Diastolic Blood Pressure at 12, 24 and 36 Months
    End point description
    Subjects were determined to have hypertension at a particular time point if standardized SBP ≥ 130 mm Hg or standardized DBP ≥ 80 mm Hg or subject had received an antihypertensive medication(s) for hypertension. The analysis was performed in the Intent-to-Treat population. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: mmHg
    arithmetic mean (standard deviation)
        Diastolic BP (Month 12) (n= 184,175,184)
    77.8 ( 13.83 )
    78.3 ( 10.62 )
    81.8 ( 11.68 )
        Systolic BP (Month 12) (n= 184,175,184)
    141.4 ( 21.29 )
    140.9 ( 21.09 )
    149.5 ( 19.81 )
        Diastolic BP (Month 24) (n= 120,129,120)
    78.2 ( 13.28 )
    77 ( 11.18 )
    81.7 ( 11.47 )
        Systolic BP (Month 24) (n= 120,129,120)
    138.8 ( 24.31 )
    136.7 ( 20.96 )
    146.8 ( 21.11 )
        Diastolic BP (Month 36) (n= 112,119,108)
    75.4 ( 11.55 )
    75.2 ( 10.85 )
    77.2 ( 11.79 )
        Systolic BP (Month 36) (n= 112,119,108)
    134.9 ( 19.54 )
    134.7 ( 21.59 )
    140.7 ( 21.19 )
    No statistical analyses for this end point

    Secondary: Mean Framingham Risk Score from Baseline to Month 12, 24 and 36

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    End point title
    		 Mean Framingham Risk Score from Baseline to Month 12, 24 and 36
    End point description
    The risk score utilized data from the Framingham Heart Study to estimate 10-year risk for ‘hard’ coronary heart disease (myocardial infarction and coronary death). The risk factors included were age, gender, total cholesterol, HDL cholesterol, SBP, diabetes, treatment for hypertension, and any cigarette use in the prior month. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Month 12
    5.3 ( 4.11 )
    4.5 ( 4.02 )
    6 ( 3.98 )
        Month 24
    5 ( 4.25 )
    4.6 ( 4.23 )
    6.2 ( 4.07 )
        Month 36
    5.2 ( 4.18 )
    4.9 ( 3.84 )
    5.8 ( 4 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Using Lipid-Lowering Therapy at 12, 24, and 36 Months

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    End point title
    		 Percentage of Subjects Using Lipid-Lowering Therapy at 12, 24, and 36 Months
    End point description
    Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low-density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. The analysis was performed in the Intent-to-Treat population. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of subjects
    number (confidence interval 95%)
        Month 12 (n = 184,175,184)
    43.5 (36.3 to 50.6)
    40 (32.7 to 47.3)
    46.2 (39 to 53.2)
        Month 24 (n = 184,175,184)
    47.8 (40.6 to 55)
    42.3 (35 to 49.6)
    51.1 (43.9 to 58.3)
        Month 36 (n = 151,145,143)
    52.3 (44.4 to 60.3)
    45.5 (37.4 to 53.6)
    60.8 (52.8 to 68.8)
    No statistical analyses for this end point

    Secondary: Change in Total Cholesterol, Non-HDL, LDL and HDL Cholesterol and Triglyceride at 12, 24 and 36 Months

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    End point title
    		 Change in Total Cholesterol, Non-HDL, LDL and HDL Cholesterol and Triglyceride at 12, 24 and 36 Months
    End point description
    Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low-density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. The analysis was performed in the Intent-to-Treat population. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: mg/dL
    arithmetic mean (standard deviation)
        Non-HDL (Month 12) (n = 184,175,184)
    134.5 ( 45.04 )
    134.2 ( 40.69 )
    153.4 ( 46.69 )
        Total Cholesterol (Month 12) (n = 184,175,184)
    183.7 ( 47.72 )
    184.1 ( 45.51 )
    201.3 ( 49.49 )
        Triglyceride (Month 12) (n = 184,175,184)
    171.9 ( 129.76 )
    153.2 ( 69.92 )
    213.8 ( 113.12 )
        HDL (Month 12) (n = 184,175,184)
    49.2 ( 13.73 )
    49.8 ( 15.85 )
    47.9 ( 14.76 )
        LDL (Month 12) (n = 184,175,184)
    104 ( 39.33 )
    102.4 ( 36.63 )
    107.8 ( 40.08 )
        Non-HDL (Month 24) (n = 119,128,111)
    126.1 ( 45.45 )
    129.8 ( 37.89 )
    148.7 ( 60.46 )
        Total Cholesterol (Month 24) (n = 119,128,111)
    175.6 ( 47.99 )
    178 ( 41.9 )
    195.7 ( 61.46 )
        Triglyceride (Month 24) (n = 98,104,93)
    152 ( 108.97 )
    147 ( 69.45 )
    208.2 ( 135.19 )
        HDL (Month 24) (n = 119,128,111)
    49.5 ( 16.27 )
    48.2 ( 14.41 )
    47 ( 17.77 )
        LDL (Month 24) (n = 97,104,93)
    96.9 ( 33.46 )
    101.4 ( 36.64 )
    108.6 ( 40.8 )
        Non-HDL (Month 36) (n = 111,117,97)
    132.6 ( 41.86 )
    132.2 ( 46.81 )
    139.1 ( 49.68 )
        Total Cholesterol (Month 36) (n = 111,117,98)
    181 ( 43.84 )
    181.9 ( 49.16 )
    196.7 ( 127.35 )
        Triglyceride (Month 36) (n = 80,88,78)
    160.7 ( 98.56 )
    154.3 ( 76.58 )
    181.3 ( 108.32 )
        HDL (Month 36) (n = 111,117,97)
    48.9 ( 14.82 )
    49.6 ( 16.24 )
    47 ( 14.28 )
        LDL (Month 36) (n = 79,88,77)
    103.1 ( 32.59 )
    106 ( 37.29 )
    102.3 ( 47.4 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Have an Acute Rejection by Month 6, 12, 24, 36 and 84

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    End point title
    		 Percentage of Subjects Who Have an Acute Rejection by Month 6, 12, 24, 36 and 84
    End point description
    Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Month 6, 12, 24, 36 and 84
    End point values
    		 Belatacept MI (Periods 1&2) Belatacept LI (Periods 1&2) Cyclosporin A (Periods 1&2)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of subjects
    number (confidence interval 95%)
        Month 6
    17.4 (11.9 to 22.9)
    16.6 (11.1 to 22.1)
    13.6 (8.6 to 18.5)
        Month 12
    17.4 (11.9 to 22.9)
    17.7 (12.1 to 23.4)
    14.1 (9.1 to 19.2)
        Month 24
    17.4 (11.9 to 22.9)
    18.3 (12.6 to 24)
    15.2 (10 to 20.4)
        Month 36
    17.9 (12.4 to 23.5)
    18.9 (13.1 to 24.7)
    15.8 (10.5 to 21.1)
        Month 84
    19 (13.4 to 24.7)
    19.4 (13.6 to 25.3)
    15.8 (10.5 to 21.1)
    No statistical analyses for this end point

    Secondary: Number of Subjects Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Month 6, 12, 24, and 36

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    End point title
    		 Number of Subjects Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Month 6, 12, 24, and 36
    End point description
    Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte-depletion therapy for treatment of an episode of acute was defined as subject treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as subjects initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte-depletion therapy. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Month 6, 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Number of subjects
    number (not applicable)
        Only corticosteroid treated (Month 6)
    14
    16
    9
        Corticosteroid resistant (Month 6)
    2
    2
    2
        Lymphocyte-depleting treated (Month 6)
    13
    5
    4
        Only corticosteroid treated (Month 12)
    14
    16
    10
        Corticosteroid resistant (Month 12)
    2
    2
    2
        Lymphocyte-depleting treated (Month 12)
    13
    5
    4
        Only corticosteroid treated (Month 24)
    13
    19
    11
        Corticosteroid resistant (Month 24)
    2
    1
    2
        Lymphocyte-depleting treated (Month 24)
    14
    7
    4
        Only corticosteroid treated (Month 36)
    13
    19
    11
        Corticosteroid resistant (Month 36)
    2
    1
    2
        Lymphocyte-depleting treated (Month 36)
    14
    7
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84.

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    End point title
    		 Number of Subjects Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84.
    End point description
    Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Month 6, 12, 24, 36 and 84
    End point values
    		 Belatacept MI (Periods 1&2) Belatacept LI (Periods 1&2) Cyclosporin A (Periods 1&2)
    Number of subjects analysed
    184
    175
    184
    Units: Subjects
        Mild acute (IA) (Month 6)
    0
    4
    2
        Mild acute (IB) (Month 6)
    6
    2
    2
        Moderate acute (IIA) (Month 6)
    11
    15
    16
        Moderate acute (IB) (Month 6)
    15
    8
    5
        Severe acute (III) (Month 6)
    0
    0
    0
        Mild acute (IA) (Month 12)
    0
    4
    2
        Mild acute (IB) (Month 12)
    6
    2
    2
        Moderate acute (IIA) (Month 12)
    11
    17
    17
        Moderate acute (IB) (Month 12)
    15
    8
    5
        Severe acute (III) (Month 12)
    0
    0
    0
        Mild acute (IA) (Month 24)
    0
    4
    2
        Mild acute (IB) (Month 24)
    6
    2
    3
        Moderate acute (IIA) (Month 24)
    10
    17
    18
        Moderate acute (IB) (Month 24)
    16
    9
    5
        Severe acute (III) (Month 24)
    0
    0
    0
        Mild acute (IA) (Month 36)
    0
    4
    2
        Mild acute (IB) (Month 36)
    6
    2
    4
        Moderate acute (IIA) (Month 36)
    10
    18
    18
        Moderate acute (IB) (Month 36)
    16
    9
    5
        Severe acute (III) (Month 36)
    1
    0
    0
        Mild acute (IA) (Month 84)
    0
    4
    2
        Mild acute (1B) (Month 84)
    6
    3
    4
        Moderate acute (IIA) (Month 84)
    12
    18
    18
        Moderate acute (IIB) (Month 84)
    16
    9
    5
        Severe acute (III) (Month 84)
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) from Baseline to Months 12, 24 and 36

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    End point title
    		 Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) from Baseline to Months 12, 24 and 36
    End point description
    The SF-36 was used to measure health-related quality of life (QoL). Individual subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and 2 summary scores (physical component score and mental component score) were calculated. The analysis was performed in the Intent-to-Treat population. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Month 12, 24, 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Physical functioning (Month 12) (n=148, 153, 155)
    44.7 ( 10.56 )
    46 ( 11.01 )
    44 ( 10.64 )
        Role-physical (Month 12) (n=148, 153, 156)
    43.6 ( 11.24 )
    43.9 ( 11.45 )
    42.3 ( 10.86 )
        Bodily pain (Month 12) (n=148, 153, 154)
    52.5 ( 10.81 )
    49.9 ( 12 )
    48.3 ( 11.23 )
        General health (Month 12) (n=148, 154, 156)
    47.6 ( 9.55 )
    46.9 ( 9.87 )
    46 ( 9.92 )
        Vitality (Month 12) (n=147, 152, 156)
    53.5 ( 9.9 )
    53.3 ( 11.54 )
    51.9 ( 10.63 )
        Social functioning (Month 12) (n=148, 153, 156)
    48.7 ( 9.8 )
    47 ( 11.22 )
    45.4 ( 11.53 )
        Role-emotional (Month 12) (n=148, 152, 154)
    44.1 ( 12.38 )
    43.5 ( 13.68 )
    44.1 ( 12.27 )
        Mental health (Month 12) (n=147, 151, 156)
    50.1 ( 10.56 )
    49.1 ( 12.43 )
    49.1 ( 11.29 )
        Physical functioning (Month 24) (n=145, 151, 153)
    43.9 ( 10.77 )
    46 ( 10.2 )
    43.1 ( 11.47 )
        Role-physical (Month 24) (n=145, 150, 151)
    43.4 ( 11.17 )
    43.9 ( 10.58 )
    42.1 ( 10.76 )
        Bodily pain (Month 24) (n=144, 152, 152)
    51.4 ( 11.09 )
    49.2 ( 11.45 )
    47.2 ( 11.87 )
        General health (Month 24) (n=147, 152, 154)
    46.8 ( 9.37 )
    46.5 ( 10.1 )
    44.6 ( 10.49 )
        Vitality (Month 24) (n=145, 150, 153)
    53.3 ( 9.8 )
    52.9 ( 11.31 )
    50.5 ( 11.07 )
        Social functioning (Month 24) (n=146, 152, 153)
    47.2 ( 10.87 )
    48.7 ( 9.35 )
    45.7 ( 11.5 )
        Role-emotional (Month 24) (n=144, 148, 147)
    44.5 ( 12.38 )
    44.3 ( 12.43 )
    43.6 ( 12.37 )
        Mental health (Month 24) (n=145, 150, 153)
    50.1 ( 10.59 )
    49.3 ( 11.81 )
    48.2 ( 11.5 )
        Physical functioning (Month 36) (n=144, 151, 153)
    43.8 ( 11.66 )
    45.5 ( 10.84 )
    43 ( 11.77 )
        Role-physical (Month 36) (n=144, 148, 152)
    43.9 ( 11 )
    43.5 ( 11.08 )
    41.9 ( 11.15 )
        Bodily pain (Month 36) (n=143, 151, 153)
    51.1 ( 11.19 )
    49.5 ( 11.76 )
    46.9 ( 11.16 )
        General health (Month 36) (n=147, 152, 154)
    46.3 ( 9.96 )
    45.4 ( 10.5 )
    43.6 ( 10.51 )
        Vitality (Month 36) (n=144, 149, 153)
    53.5 ( 10.07 )
    52.3 ( 11.94 )
    50.5 ( 11.26 )
        Social functioning (Month 36) (n=146, 152, 154)
    46.9 ( 10.64 )
    48.3 ( 10.1 )
    45.1 ( 11.57 )
        Role-emotional (Month 36) (n=144, 146, 148)
    44.2 ( 12.74 )
    43.5 ( 12.73 )
    43.1 ( 12.96 )
        Mental health (Month 36) (n=144, 149, 153)
    50.8 ( 9.35 )
    48.1 ( 12.31 )
    47.7 ( 11.19 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Changes in Vital Signs up to 36 Months

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    End point title
    		 Number of Subjects with Clinically Significant Changes in Vital Signs up to 36 Months
    End point description
    Subjects with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Subjects
        Heart rate
    0
    0
    0
        Body temperature
    0
    0
    0
        Body weight
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Laboratory Test Abnormalities up to 36 Months

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    End point title
    		 Number of Subjects with Laboratory Test Abnormalities up to 36 Months
    End point description
    Subjects with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analysed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to te Common Terminology Criteria for Adverse Events (CTCAE) version 3. The analysis was performed in the Intent-to-Treat population. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Subjects
        Hemoglobin (Low) (n=177,172,181)
    25
    24
    16
        Platelet Count (Low) (n=177,172,181)
    2
    1
    2
        Leukocytes (Low) (n=177,172,181)
    10
    5
    8
        ALP (High) (n=177,172,182)
    1
    1
    0
        ALT (High) (n=177,172,181)
    4
    2
    4
        AST (High) (n=177,172,181)
    1
    1
    0
        Bilirubin, Total (High) (n=177,172,182)
    0
    2
    1
        Creatinine (High) (n=177,172,182)
    125
    117
    128
        Calcium, Total (Low) (n=177,172,182)
    19
    14
    10
        Calcium, Total (High) (n=177,172,182)
    2
    2
    1
        Bicarbonate (Low) (n=176,171,181)
    2
    1
    2
        Bicarbonate (High) (n=176,171,181)
    0
    0
    0
        Potassium, Serum (Low) (n=177,172,181)
    6
    3
    9
        Potassium, Serum (High) (n=177,172,181)
    8
    6
    11
        Magnesium, Serum (Low) (n=177,172,181)
    6
    3
    1
        Magnesium, Serum (High) (n=177,172,181)
    6
    4
    9
        Sodium, Serum (Low) (n=177,172,182)
    18
    16
    23
        Sodium, Serum (High) (n=177,172,182)
    0
    0
    1
        Phosphorus (Low) (n=177,172,182)
    66
    58
    44
        Albumin (Low) (n=177,172,182)
    2
    4
    1
        Uric Acid (High) (n=177,172,182)
    31
    34
    60
        Protein, Urine (High) (n=173,168,177)
    44
    37
    43
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36

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    End point title
    		 Number of Subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
    End point description
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 36
    End point values
    		 Belatacept MI (Period 1) Belatacept LI (Period 1) Cyclosporin A (Period 1)
    Number of subjects analysed
    184
    175
    184
    Units: Subjects
        AEs
    182
    174
    184
        SAEs
    149
    139
    146
        AEs leading to Discontinuation
    34
    36
    44
        SAEs leading to Discontinuation
    31
    31
    28
        Related AEs
    115
    106
    141
        Related SAEs
    60
    51
    58
        Deaths
    22
    15
    17
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84

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    End point title
    		 Number of Subjects with Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84
    End point description
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed in the Intent-to-Treat population.
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 84
    End point values
    		 Belatacept MI (Periods 1&2) Belatacept LI (Periods 1&2) Cyclosporin A (Periods 1&2)
    Number of subjects analysed
    184
    175
    184
    Units: Subjects
        AEs
    104
    113
    87
        SAEs
    94
    104
    73
        AEs leading to Discontinuation
    14
    14
    7
        SAEs leading to Discontinuation
    10
    13
    7
        Deaths
    14
    21
    9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Graft Loss or Death to Month 84

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    End point title
    		 Percentage of Subjects with Graft Loss or Death to Month 84
    End point description
    Subject and graft survival at 84 months was summarized within each treatment group. The analyses was performed in the Intent-to-Treat population which includes all subjects who are randomized into the study and received a transplant.
    End point type
    Secondary
    End point timeframe
    Randomization to date of death, up to 84 months
    End point values
    		 Belatacept MI (Periods 1&2) Belatacept LI (Periods 1&2) Cyclosporin A (Periods 1&2)
    Number of subjects analysed
    184
    175
    184
    Units: Percentage of Subjects
    number (not applicable)
        Graft Loss or Death
    29.3
    30.9
    28.3
        Graft Loss
    11.4
    13.1
    15.8
        Death
    20.1
    21.1
    15.8
        Death with Functioning Graft
    17.9
    17.7
    12.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline up to 56 days after the last dose of the study drug
    Adverse event reporting additional description
    On treatment-period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Belatacept MI
    Reporting group description
    		 Subjects in more intensive (MI) regimen received belatacept 10 mg/kg intravenous solution on Day 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.

    Reporting group title
    Belatacept LI
    Reporting group description
    		 Subjects in less intensive (LI) regimen received belatacept, 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.

    Reporting group title
    Cyclosporin A
    Reporting group description
    		 Subjects received an initial daily dose of 4 -10 mg/kg cyclosporine capsules orally, in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL. Subsequent doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.

    Serious adverse events
    		 Belatacept MI Belatacept LI Cyclosporin A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    162 / 183 (88.52%)
    157 / 177 (88.70%)
    152 / 179 (84.92%)
         number of deaths (all causes)
    35
    35
    29
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    9 / 183 (4.92%)
    6 / 177 (3.39%)
    12 / 179 (6.70%)
         occurrences causally related to treatment / all
    8 / 16
    10 / 11
    7 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    8 / 183 (4.37%)
    6 / 177 (3.39%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    7 / 14
    6 / 8
    13 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 183 (1.09%)
    4 / 177 (2.26%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    4 / 183 (2.19%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kaposi's sarcoma
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Squamous cell carcinoma
         subjects affected / exposed
    3 / 183 (1.64%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    3 / 177 (1.69%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    Renal cell carcinoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Epiglottic carcinoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Malignant pleural effusion
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural mesothelioma malignant
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Lymphocele
         subjects affected / exposed
    2 / 183 (1.09%)
    5 / 177 (2.82%)
    11 / 179 (6.15%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 7
    2 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    7 / 183 (3.83%)
    4 / 177 (2.26%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 183 (1.09%)
    5 / 177 (2.82%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 183 (2.19%)
    4 / 177 (2.26%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    2 / 183 (1.09%)
    3 / 177 (1.69%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 183 (0.00%)
    3 / 177 (1.69%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Angiopathy
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Aortic dissection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic infarction
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Lymphoedema
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular stenosis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous stenosis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    17 / 183 (9.29%)
    10 / 177 (5.65%)
    12 / 179 (6.70%)
         occurrences causally related to treatment / all
    2 / 19
    3 / 16
    4 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    5 / 183 (2.73%)
    3 / 177 (1.69%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic cyst
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multi -organ failure
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cyst
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extravasation
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 183 (1.09%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 183 (0.55%)
    3 / 177 (1.69%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acquired hydrocele
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Priapism
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatism
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal oedema
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular swelling
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine malposition
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 183 (1.09%)
    4 / 177 (2.26%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    5 / 179 (2.79%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Pulmonary oedema
         subjects affected / exposed
    3 / 183 (1.64%)
    3 / 177 (1.69%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    2 / 183 (1.09%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial secretion retention
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mediastinal disorder
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthopnoea
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal oedema
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Acute psychosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    14 / 183 (7.65%)
    11 / 177 (6.21%)
    17 / 179 (9.50%)
         occurrences causally related to treatment / all
    2 / 14
    1 / 14
    6 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood creatine increased
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Antibody test positive
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood glucose abnormal
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcus test positive
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia test positive
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyomavirus test positive
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cells urine positive
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Transplant dysfunction
         subjects affected / exposed
    9 / 183 (4.92%)
    6 / 177 (3.39%)
    11 / 179 (6.15%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 6
    3 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    3 / 183 (1.64%)
    8 / 177 (4.52%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 10
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Graft loss
         subjects affected / exposed
    4 / 183 (2.19%)
    7 / 177 (3.95%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic allograft nephropathy
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    5 / 179 (2.79%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 183 (0.55%)
    5 / 177 (2.82%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 183 (0.00%)
    4 / 177 (2.26%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perirenal haematoma
         subjects affected / exposed
    2 / 183 (1.09%)
    3 / 177 (1.69%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    1 / 183 (0.55%)
    3 / 177 (1.69%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Graft complication
         subjects affected / exposed
    3 / 183 (1.64%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula aneurysm
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 183 (0.00%)
    3 / 177 (1.69%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural urine leak
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Shunt occlusion
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incorrect dose administered
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Seroma
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transplant failure
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic complication
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula occlusion
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract operation complication
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complications of transplant surgery
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incision site complication
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incision site haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kidney rupture
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perinephric collection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    9 / 183 (4.92%)
    11 / 177 (6.21%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 11
    1 / 14
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    10 / 183 (5.46%)
    5 / 177 (2.82%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    7 / 183 (3.83%)
    3 / 177 (1.69%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    Cardiac failure
         subjects affected / exposed
    3 / 183 (1.64%)
    3 / 177 (1.69%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Acute myocardial infarction
         subjects affected / exposed
    2 / 183 (1.09%)
    4 / 177 (2.26%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Acute coronary syndrome
         subjects affected / exposed
    1 / 183 (0.55%)
    3 / 177 (1.69%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 183 (1.09%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    3 / 183 (1.64%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Arrhythmia
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Supraventricular tachyarrhythmia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    6 / 183 (3.28%)
    1 / 177 (0.56%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    Convulsion
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    3 / 183 (1.64%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain mass
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis toxic
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mononeuropathy
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 183 (6.01%)
    9 / 177 (5.08%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    1 / 11
    2 / 9
    4 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    8 / 183 (4.37%)
    2 / 177 (1.13%)
    5 / 179 (2.79%)
         occurrences causally related to treatment / all
    3 / 9
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 183 (1.64%)
    2 / 177 (1.13%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aplasia pure red cell
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Granulocytopenia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercoagulation
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    18 / 183 (9.84%)
    14 / 177 (7.91%)
    10 / 179 (5.59%)
         occurrences causally related to treatment / all
    1 / 20
    5 / 16
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 183 (1.09%)
    2 / 177 (1.13%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 183 (1.09%)
    3 / 177 (1.69%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastritis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastric ulcer
         subjects affected / exposed
    3 / 183 (1.64%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestine obstruction
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernial eventration
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenal ulcer
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    Large intestine polyp
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gingival hyperplasia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gingival hypertrophy
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Malabsorption
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral disorder
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritoneal disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder perforation
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic mass
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic bullosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    7 / 183 (3.83%)
    12 / 177 (6.78%)
    11 / 179 (6.15%)
         occurrences causally related to treatment / all
    1 / 17
    1 / 12
    2 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    2 / 183 (1.09%)
    5 / 177 (2.82%)
    7 / 179 (3.91%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    2 / 183 (1.09%)
    3 / 177 (1.69%)
    9 / 179 (5.03%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    4 / 183 (2.19%)
    3 / 177 (1.69%)
    4 / 179 (2.23%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    4 / 183 (2.19%)
    2 / 177 (1.13%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    4 / 183 (2.19%)
    3 / 177 (1.69%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal vein thrombosis
         subjects affected / exposed
    6 / 183 (3.28%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary fistula
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive uropathy
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal tubular disorder
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder prolapse
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neck sclerosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder obstruction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertonic bladder
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Microalbuminuria
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perinephric effusion
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postrenal failure
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelocaliectasis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal artery dissection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst haemorrhage
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal tubular atrophy
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteral necrosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric dilatation
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric fistula
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urine abnormality
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vesical fistula
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal mass
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism tertiary
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercreatinaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post transplant distal limb syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    25 / 183 (13.66%)
    28 / 177 (15.82%)
    26 / 179 (14.53%)
         occurrences causally related to treatment / all
    8 / 39
    6 / 36
    9 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    18 / 183 (9.84%)
    16 / 177 (9.04%)
    13 / 179 (7.26%)
         occurrences causally related to treatment / all
    17 / 29
    10 / 18
    4 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    15 / 183 (8.20%)
    14 / 177 (7.91%)
    11 / 179 (6.15%)
         occurrences causally related to treatment / all
    6 / 21
    8 / 20
    4 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    Sepsis
         subjects affected / exposed
    8 / 183 (4.37%)
    10 / 177 (5.65%)
    15 / 179 (8.38%)
         occurrences causally related to treatment / all
    1 / 10
    2 / 10
    4 / 16
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    2 / 4
    Pyelonephritis
         subjects affected / exposed
    12 / 183 (6.56%)
    6 / 177 (3.39%)
    14 / 179 (7.82%)
         occurrences causally related to treatment / all
    4 / 17
    3 / 6
    2 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gatroenteritis
         subjects affected / exposed
    8 / 183 (4.37%)
    6 / 177 (3.39%)
    8 / 179 (4.47%)
         occurrences causally related to treatment / all
    1 / 8
    2 / 6
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    6 / 183 (3.28%)
    7 / 177 (3.95%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    2 / 8
    1 / 7
    3 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Herpes zoster
         subjects affected / exposed
    8 / 183 (4.37%)
    3 / 177 (1.69%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    3 / 8
    1 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    4 / 183 (2.19%)
    1 / 177 (0.56%)
    7 / 179 (3.91%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 183 (1.09%)
    2 / 177 (1.13%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    1 / 5
    Bacteraemia
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    5 / 179 (2.79%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 183 (1.64%)
    3 / 177 (1.69%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    5 / 183 (2.73%)
    4 / 177 (2.26%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    5 / 179 (2.79%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 183 (1.64%)
    3 / 177 (1.69%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 183 (0.55%)
    3 / 177 (1.69%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    4 / 183 (2.19%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    4 / 183 (2.19%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    3 / 183 (1.64%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    3 / 183 (1.64%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 183 (0.55%)
    3 / 177 (1.69%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    3 / 183 (1.64%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 183 (0.55%)
    4 / 177 (2.26%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cyst infection
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cryptococcosis
         subjects affected / exposed
    1 / 183 (0.55%)
    3 / 177 (1.69%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    3 / 179 (1.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis cryptococcal
         subjects affected / exposed
    2 / 183 (1.09%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    3 / 183 (1.64%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transplant abscess
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterobacter infection
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Strongyloidiasis
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 183 (0.00%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess rupture
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BK virus infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral aspergillosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral fungal infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Chorioretinitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis bacterial
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus chorioretinitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus enteritis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus gastritis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus gastroenteritis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus gastrointestinal infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus hepatitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus syndrome
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated cytomegaloviral infection
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Emphysematous cystitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalomyelitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Human polyomavirus infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incision site infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint tuberculosis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leishmaniasis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral fungal infection
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cryptococcal
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Purulent discharge
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection fungal
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis bacterial
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis of eye
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis laryngitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    7 / 183 (3.83%)
    10 / 177 (5.65%)
    6 / 179 (3.35%)
         occurrences causally related to treatment / all
    1 / 7
    2 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    3 / 183 (1.64%)
    4 / 177 (2.26%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 183 (1.09%)
    3 / 177 (1.69%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 183 (1.09%)
    1 / 177 (0.56%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 183 (1.09%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    2 / 179 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 177 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercreatininaemia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Belatacept MI Belatacept LI Cyclosporin A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    177 / 183 (96.72%)
    171 / 177 (96.61%)
    179 / 179 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    11 / 183 (6.01%)
    6 / 177 (3.39%)
    11 / 179 (6.15%)
         occurrences all number
    23
    7
    22
    Vascular disorders
    Hypertension
         subjects affected / exposed
    63 / 183 (34.43%)
    63 / 177 (35.59%)
    80 / 179 (44.69%)
         occurrences all number
    131
    170
    190
    Hypotension
         subjects affected / exposed
    38 / 183 (20.77%)
    52 / 177 (29.38%)
    29 / 179 (16.20%)
         occurrences all number
    69
    86
    54
    Haematoma
         subjects affected / exposed
    16 / 183 (8.74%)
    16 / 177 (9.04%)
    18 / 179 (10.06%)
         occurrences all number
    27
    22
    23
    Lymphocele
         subjects affected / exposed
    9 / 183 (4.92%)
    7 / 177 (3.95%)
    15 / 179 (8.38%)
         occurrences all number
    18
    20
    42
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    92 / 183 (50.27%)
    81 / 177 (45.76%)
    96 / 179 (53.63%)
         occurrences all number
    295
    269
    412
    Pyrexia
         subjects affected / exposed
    56 / 183 (30.60%)
    64 / 177 (36.16%)
    52 / 179 (29.05%)
         occurrences all number
    98
    107
    112
    Oedema
         subjects affected / exposed
    26 / 183 (14.21%)
    23 / 177 (12.99%)
    30 / 179 (16.76%)
         occurrences all number
    65
    68
    51
    Chest pain
         subjects affected / exposed
    22 / 183 (12.02%)
    24 / 177 (13.56%)
    24 / 179 (13.41%)
         occurrences all number
    34
    42
    46
    Fatigue
         subjects affected / exposed
    26 / 183 (14.21%)
    22 / 177 (12.43%)
    19 / 179 (10.61%)
         occurrences all number
    41
    44
    39
    Asthenia
         subjects affected / exposed
    23 / 183 (12.57%)
    17 / 177 (9.60%)
    23 / 179 (12.85%)
         occurrences all number
    42
    35
    53
    Pain
         subjects affected / exposed
    13 / 183 (7.10%)
    13 / 177 (7.34%)
    14 / 179 (7.82%)
         occurrences all number
    29
    15
    31
    Peripheral swelling
         subjects affected / exposed
    10 / 183 (5.46%)
    14 / 177 (7.91%)
    12 / 179 (6.70%)
         occurrences all number
    24
    31
    23
    Chills
         subjects affected / exposed
    9 / 183 (4.92%)
    6 / 177 (3.39%)
    9 / 179 (5.03%)
         occurrences all number
    11
    8
    10
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    12 / 183 (6.56%)
    9 / 177 (5.08%)
    5 / 179 (2.79%)
         occurrences all number
    18
    14
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    53 / 183 (28.96%)
    56 / 177 (31.64%)
    41 / 179 (22.91%)
         occurrences all number
    155
    138
    103
    Dyspnoea
         subjects affected / exposed
    33 / 183 (18.03%)
    40 / 177 (22.60%)
    37 / 179 (20.67%)
         occurrences all number
    67
    90
    85
    Oropharyngeal pain
         subjects affected / exposed
    16 / 183 (8.74%)
    9 / 177 (5.08%)
    11 / 179 (6.15%)
         occurrences all number
    26
    17
    13
    Dyspnoea exertional
         subjects affected / exposed
    15 / 183 (8.20%)
    10 / 177 (5.65%)
    8 / 179 (4.47%)
         occurrences all number
    27
    20
    22
    Productive cough
         subjects affected / exposed
    9 / 183 (4.92%)
    18 / 177 (10.17%)
    6 / 179 (3.35%)
         occurrences all number
    18
    36
    12
    Nasal congestion
         subjects affected / exposed
    5 / 183 (2.73%)
    1 / 177 (0.56%)
    9 / 179 (5.03%)
         occurrences all number
    7
    1
    12
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    37 / 183 (20.22%)
    31 / 177 (17.51%)
    39 / 179 (21.79%)
         occurrences all number
    92
    56
    77
    Anxiety
         subjects affected / exposed
    27 / 183 (14.75%)
    20 / 177 (11.30%)
    30 / 179 (16.76%)
         occurrences all number
    55
    33
    48
    Depression
         subjects affected / exposed
    8 / 183 (4.37%)
    16 / 177 (9.04%)
    18 / 179 (10.06%)
         occurrences all number
    22
    43
    30
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    29 / 183 (15.85%)
    29 / 177 (16.38%)
    31 / 179 (17.32%)
         occurrences all number
    63
    71
    71
    Weight decreased
         subjects affected / exposed
    17 / 183 (9.29%)
    21 / 177 (11.86%)
    13 / 179 (7.26%)
         occurrences all number
    32
    45
    20
    Weight increased
         subjects affected / exposed
    15 / 183 (8.20%)
    13 / 177 (7.34%)
    11 / 179 (6.15%)
         occurrences all number
    30
    24
    18
    C-reactive protein increased
         subjects affected / exposed
    12 / 183 (6.56%)
    14 / 177 (7.91%)
    11 / 179 (6.15%)
         occurrences all number
    30
    36
    22
    Blood pressure increased
         subjects affected / exposed
    8 / 183 (4.37%)
    5 / 177 (2.82%)
    10 / 179 (5.59%)
         occurrences all number
    12
    8
    16
    Injury, poisoning and procedural complications
    Transplant dysfunction
         subjects affected / exposed
    65 / 183 (35.52%)
    64 / 177 (36.16%)
    85 / 179 (47.49%)
         occurrences all number
    129
    117
    176
    Procedural pain
         subjects affected / exposed
    36 / 183 (19.67%)
    38 / 177 (21.47%)
    37 / 179 (20.67%)
         occurrences all number
    74
    59
    62
    Incision site pain
         subjects affected / exposed
    26 / 183 (14.21%)
    22 / 177 (12.43%)
    36 / 179 (20.11%)
         occurrences all number
    52
    43
    71
    Complications of transplanted kidney
         subjects affected / exposed
    10 / 183 (5.46%)
    20 / 177 (11.30%)
    17 / 179 (9.50%)
         occurrences all number
    14
    39
    42
    Chronic allograft nephropathy
         subjects affected / exposed
    14 / 183 (7.65%)
    9 / 177 (5.08%)
    22 / 179 (12.29%)
         occurrences all number
    21
    11
    23
    Fall
         subjects affected / exposed
    16 / 183 (8.74%)
    8 / 177 (4.52%)
    11 / 179 (6.15%)
         occurrences all number
    23
    12
    18
    Contusion
         subjects affected / exposed
    8 / 183 (4.37%)
    11 / 177 (6.21%)
    4 / 179 (2.23%)
         occurrences all number
    21
    19
    13
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    4 / 183 (2.19%)
    7 / 177 (3.95%)
    9 / 179 (5.03%)
         occurrences all number
    5
    10
    14
    Toxicity to various agents
         subjects affected / exposed
    1 / 183 (0.55%)
    1 / 177 (0.56%)
    18 / 179 (10.06%)
         occurrences all number
    1
    1
    27
    Ligament sprain
         subjects affected / exposed
    8 / 183 (4.37%)
    1 / 177 (0.56%)
    10 / 179 (5.59%)
         occurrences all number
    14
    2
    16
    Wound dehiscence
         subjects affected / exposed
    3 / 183 (1.64%)
    5 / 177 (2.82%)
    10 / 179 (5.59%)
         occurrences all number
    14
    14
    17
    Wound complication
         subjects affected / exposed
    3 / 183 (1.64%)
    5 / 177 (2.82%)
    9 / 179 (5.03%)
         occurrences all number
    4
    9
    14
    Post procedural discharge
         subjects affected / exposed
    1 / 183 (0.55%)
    2 / 177 (1.13%)
    9 / 179 (5.03%)
         occurrences all number
    1
    2
    15
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    14 / 183 (7.65%)
    22 / 177 (12.43%)
    12 / 179 (6.70%)
         occurrences all number
    17
    47
    24
    Atrial fibrillation
         subjects affected / exposed
    16 / 183 (8.74%)
    11 / 177 (6.21%)
    12 / 179 (6.70%)
         occurrences all number
    27
    28
    21
    Bradycardia
         subjects affected / exposed
    10 / 183 (5.46%)
    7 / 177 (3.95%)
    12 / 179 (6.70%)
         occurrences all number
    13
    14
    18
    Angina pectoris
         subjects affected / exposed
    5 / 183 (2.73%)
    8 / 177 (4.52%)
    12 / 179 (6.70%)
         occurrences all number
    7
    10
    15
    Sinus bradycardia
         subjects affected / exposed
    8 / 183 (4.37%)
    4 / 177 (2.26%)
    9 / 179 (5.03%)
         occurrences all number
    9
    6
    11
    Left ventricular hypertrophy
         subjects affected / exposed
    5 / 183 (2.73%)
    9 / 177 (5.08%)
    6 / 179 (3.35%)
         occurrences all number
    7
    12
    11
    Nervous system disorders
    Headache
         subjects affected / exposed
    37 / 183 (20.22%)
    41 / 177 (23.16%)
    47 / 179 (26.26%)
         occurrences all number
    95
    108
    110
    Tremor
         subjects affected / exposed
    17 / 183 (9.29%)
    21 / 177 (11.86%)
    31 / 179 (17.32%)
         occurrences all number
    29
    38
    56
    Dizziness
         subjects affected / exposed
    26 / 183 (14.21%)
    18 / 177 (10.17%)
    18 / 179 (10.06%)
         occurrences all number
    47
    32
    33
    Paraesthesia
         subjects affected / exposed
    11 / 183 (6.01%)
    13 / 177 (7.34%)
    16 / 179 (8.94%)
         occurrences all number
    17
    23
    37
    Sciatica
         subjects affected / exposed
    7 / 183 (3.83%)
    11 / 177 (6.21%)
    8 / 179 (4.47%)
         occurrences all number
    10
    22
    11
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    98 / 183 (53.55%)
    93 / 177 (52.54%)
    103 / 179 (57.54%)
         occurrences all number
    286
    281
    270
    Leukopenia
         subjects affected / exposed
    51 / 183 (27.87%)
    40 / 177 (22.60%)
    48 / 179 (26.82%)
         occurrences all number
    135
    86
    126
    Thrombocytopenia
         subjects affected / exposed
    24 / 183 (13.11%)
    13 / 177 (7.34%)
    11 / 179 (6.15%)
         occurrences all number
    48
    29
    30
    Leukocytosis
         subjects affected / exposed
    15 / 183 (8.20%)
    12 / 177 (6.78%)
    9 / 179 (5.03%)
         occurrences all number
    32
    14
    18
    Neutropenia
         subjects affected / exposed
    12 / 183 (6.56%)
    10 / 177 (5.65%)
    12 / 179 (6.70%)
         occurrences all number
    20
    21
    27
    Lymphopenia
         subjects affected / exposed
    10 / 183 (5.46%)
    12 / 177 (6.78%)
    8 / 179 (4.47%)
         occurrences all number
    23
    20
    15
    Polycythaemia
         subjects affected / exposed
    4 / 183 (2.19%)
    10 / 177 (5.65%)
    7 / 179 (3.91%)
         occurrences all number
    15
    17
    15
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    5 / 183 (2.73%)
    14 / 177 (7.91%)
    8 / 179 (4.47%)
         occurrences all number
    7
    19
    13
    Eye disorders
    Cataract
         subjects affected / exposed
    20 / 183 (10.93%)
    13 / 177 (7.34%)
    16 / 179 (8.94%)
         occurrences all number
    27
    21
    34
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    103 / 183 (56.28%)
    94 / 177 (53.11%)
    74 / 179 (41.34%)
         occurrences all number
    358
    304
    196
    Constipation
         subjects affected / exposed
    61 / 183 (33.33%)
    63 / 177 (35.59%)
    79 / 179 (44.13%)
         occurrences all number
    149
    132
    177
    Nausea
         subjects affected / exposed
    54 / 183 (29.51%)
    49 / 177 (27.68%)
    52 / 179 (29.05%)
         occurrences all number
    113
    95
    98
    Vomiting
         subjects affected / exposed
    37 / 183 (20.22%)
    51 / 177 (28.81%)
    44 / 179 (24.58%)
         occurrences all number
    64
    87
    88
    Abdominal pain
         subjects affected / exposed
    30 / 183 (16.39%)
    39 / 177 (22.03%)
    33 / 179 (18.44%)
         occurrences all number
    55
    75
    66
    Abdominal pain upper
         subjects affected / exposed
    21 / 183 (11.48%)
    25 / 177 (14.12%)
    27 / 179 (15.08%)
         occurrences all number
    37
    43
    55
    Dyspepsia
         subjects affected / exposed
    22 / 183 (12.02%)
    16 / 177 (9.04%)
    20 / 179 (11.17%)
         occurrences all number
    38
    29
    29
    Abdominal distension
         subjects affected / exposed
    13 / 183 (7.10%)
    13 / 177 (7.34%)
    19 / 179 (10.61%)
         occurrences all number
    25
    20
    34
    Haemorrhoids
         subjects affected / exposed
    16 / 183 (8.74%)
    13 / 177 (7.34%)
    8 / 179 (4.47%)
         occurrences all number
    31
    30
    12
    Aphthous stomatitis
         subjects affected / exposed
    10 / 183 (5.46%)
    13 / 177 (7.34%)
    4 / 179 (2.23%)
         occurrences all number
    31
    33
    6
    Gastrooesophageal reflux disease
         subjects affected / exposed
    9 / 183 (4.92%)
    9 / 177 (5.08%)
    9 / 179 (5.03%)
         occurrences all number
    9
    12
    12
    Gastritis
         subjects affected / exposed
    8 / 183 (4.37%)
    7 / 177 (3.95%)
    9 / 179 (5.03%)
         occurrences all number
    15
    19
    12
    Flatulence
         subjects affected / exposed
    5 / 183 (2.73%)
    5 / 177 (2.82%)
    10 / 179 (5.59%)
         occurrences all number
    13
    9
    17
    Gingival hypertrophy
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 177 (0.56%)
    9 / 179 (5.03%)
         occurrences all number
    0
    1
    22
    Gingival hyperplasia
         subjects affected / exposed
    0 / 183 (0.00%)
    0 / 177 (0.00%)
    9 / 179 (5.03%)
         occurrences all number
    0
    0
    20
    Skin and subcutaneous tissue disorders
    Skin lesion
         subjects affected / exposed
    18 / 183 (9.84%)
    15 / 177 (8.47%)
    11 / 179 (6.15%)
         occurrences all number
    35
    28
    18
    Acne
         subjects affected / exposed
    7 / 183 (3.83%)
    12 / 177 (6.78%)
    15 / 179 (8.38%)
         occurrences all number
    16
    24
    34
    Pruritus
         subjects affected / exposed
    16 / 183 (8.74%)
    8 / 177 (4.52%)
    6 / 179 (3.35%)
         occurrences all number
    26
    9
    10
    Ecchymosis
         subjects affected / exposed
    13 / 183 (7.10%)
    4 / 177 (2.26%)
    9 / 179 (5.03%)
         occurrences all number
    30
    8
    15
    Hyperkeratosis
         subjects affected / exposed
    8 / 183 (4.37%)
    9 / 177 (5.08%)
    5 / 179 (2.79%)
         occurrences all number
    16
    15
    9
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    41 / 183 (22.40%)
    39 / 177 (22.03%)
    36 / 179 (20.11%)
         occurrences all number
    88
    89
    69
    Proteinuria
         subjects affected / exposed
    40 / 183 (21.86%)
    36 / 177 (20.34%)
    29 / 179 (16.20%)
         occurrences all number
    89
    90
    75
    Renal tubular necrosis
         subjects affected / exposed
    17 / 183 (9.29%)
    21 / 177 (11.86%)
    30 / 179 (16.76%)
         occurrences all number
    29
    34
    78
    Dysuria
         subjects affected / exposed
    25 / 183 (13.66%)
    23 / 177 (12.99%)
    16 / 179 (8.94%)
         occurrences all number
    53
    36
    26
    Renal impairment
         subjects affected / exposed
    13 / 183 (7.10%)
    13 / 177 (7.34%)
    19 / 179 (10.61%)
         occurrences all number
    25
    25
    41
    Leukocyturia
         subjects affected / exposed
    13 / 183 (7.10%)
    14 / 177 (7.91%)
    12 / 179 (6.70%)
         occurrences all number
    53
    41
    58
    Hydronephrosis
         subjects affected / exposed
    9 / 183 (4.92%)
    2 / 177 (1.13%)
    11 / 179 (6.15%)
         occurrences all number
    11
    3
    18
    Urinary retention
         subjects affected / exposed
    5 / 183 (2.73%)
    6 / 177 (3.39%)
    11 / 179 (6.15%)
         occurrences all number
    8
    8
    23
    Renal failure acute
         subjects affected / exposed
    4 / 183 (2.19%)
    7 / 177 (3.95%)
    9 / 179 (5.03%)
         occurrences all number
    4
    11
    12
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    7 / 183 (3.83%)
    5 / 177 (2.82%)
    12 / 179 (6.70%)
         occurrences all number
    10
    5
    17
    Cushingoid
         subjects affected / exposed
    6 / 183 (3.28%)
    7 / 177 (3.95%)
    9 / 179 (5.03%)
         occurrences all number
    8
    11
    13
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    41 / 183 (22.40%)
    44 / 177 (24.86%)
    39 / 179 (21.79%)
         occurrences all number
    100
    98
    81
    Pain in extremity
         subjects affected / exposed
    35 / 183 (19.13%)
    34 / 177 (19.21%)
    42 / 179 (23.46%)
         occurrences all number
    78
    69
    116
    Arthralgia
         subjects affected / exposed
    33 / 183 (18.03%)
    43 / 177 (24.29%)
    34 / 179 (18.99%)
         occurrences all number
    76
    97
    77
    Muscle spasms
         subjects affected / exposed
    17 / 183 (9.29%)
    17 / 177 (9.60%)
    19 / 179 (10.61%)
         occurrences all number
    28
    38
    34
    Musculoskeletal pain
         subjects affected / exposed
    13 / 183 (7.10%)
    15 / 177 (8.47%)
    10 / 179 (5.59%)
         occurrences all number
    22
    34
    14
    Myalgia
         subjects affected / exposed
    11 / 183 (6.01%)
    9 / 177 (5.08%)
    17 / 179 (9.50%)
         occurrences all number
    19
    13
    26
    Osteoporosis
         subjects affected / exposed
    13 / 183 (7.10%)
    7 / 177 (3.95%)
    5 / 179 (2.79%)
         occurrences all number
    17
    18
    5
    Osteopenia
         subjects affected / exposed
    10 / 183 (5.46%)
    7 / 177 (3.95%)
    6 / 179 (3.35%)
         occurrences all number
    12
    7
    12
    Neck pain
         subjects affected / exposed
    5 / 183 (2.73%)
    5 / 177 (2.82%)
    9 / 179 (5.03%)
         occurrences all number
    6
    7
    13
    Muscular weakness
         subjects affected / exposed
    4 / 183 (2.19%)
    4 / 177 (2.26%)
    10 / 179 (5.59%)
         occurrences all number
    7
    6
    14
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    79 / 183 (43.17%)
    76 / 177 (42.94%)
    86 / 179 (48.04%)
         occurrences all number
    364
    293
    347
    Nasopharyngitis
         subjects affected / exposed
    45 / 183 (24.59%)
    44 / 177 (24.86%)
    38 / 179 (21.23%)
         occurrences all number
    135
    139
    99
    Bronchitis
         subjects affected / exposed
    37 / 183 (20.22%)
    36 / 177 (20.34%)
    25 / 179 (13.97%)
         occurrences all number
    83
    84
    57
    Cytomegalovirus infection
         subjects affected / exposed
    22 / 183 (12.02%)
    18 / 177 (10.17%)
    17 / 179 (9.50%)
         occurrences all number
    82
    64
    41
    Upper respiratory tract infection
         subjects affected / exposed
    35 / 183 (19.13%)
    29 / 177 (16.38%)
    23 / 179 (12.85%)
         occurrences all number
    108
    96
    81
    Sinusitis
         subjects affected / exposed
    19 / 183 (10.38%)
    23 / 177 (12.99%)
    20 / 179 (11.17%)
         occurrences all number
    48
    51
    58
    Herpes zoster
         subjects affected / exposed
    21 / 183 (11.48%)
    17 / 177 (9.60%)
    13 / 179 (7.26%)
         occurrences all number
    47
    34
    21
    Influenza
         subjects affected / exposed
    17 / 183 (9.29%)
    16 / 177 (9.04%)
    18 / 179 (10.06%)
         occurrences all number
    30
    38
    29
    Gastroenteritis
         subjects affected / exposed
    8 / 183 (4.37%)
    18 / 177 (10.17%)
    22 / 179 (12.29%)
         occurrences all number
    13
    26
    29
    Oral candidiasis
         subjects affected / exposed
    14 / 183 (7.65%)
    10 / 177 (5.65%)
    13 / 179 (7.26%)
         occurrences all number
    31
    27
    22
    Oral herpes
         subjects affected / exposed
    13 / 183 (7.10%)
    14 / 177 (7.91%)
    9 / 179 (5.03%)
         occurrences all number
    34
    26
    18
    Pneumonia
         subjects affected / exposed
    7 / 183 (3.83%)
    15 / 177 (8.47%)
    11 / 179 (6.15%)
         occurrences all number
    9
    21
    18
    Conjunctivitis
         subjects affected / exposed
    15 / 183 (8.20%)
    9 / 177 (5.08%)
    7 / 179 (3.91%)
         occurrences all number
    25
    17
    11
    Rhinitis
         subjects affected / exposed
    11 / 183 (6.01%)
    8 / 177 (4.52%)
    11 / 179 (6.15%)
         occurrences all number
    14
    12
    18
    Escherichia urinary tract infection
         subjects affected / exposed
    9 / 183 (4.92%)
    6 / 177 (3.39%)
    13 / 179 (7.26%)
         occurrences all number
    47
    11
    25
    Onychomycosis
         subjects affected / exposed
    14 / 183 (7.65%)
    6 / 177 (3.39%)
    8 / 179 (4.47%)
         occurrences all number
    33
    9
    14
    Fungal skin infection
         subjects affected / exposed
    8 / 183 (4.37%)
    9 / 177 (5.08%)
    8 / 179 (4.47%)
         occurrences all number
    19
    16
    14
    Respiratory tract infection
         subjects affected / exposed
    6 / 183 (3.28%)
    13 / 177 (7.34%)
    6 / 179 (3.35%)
         occurrences all number
    11
    31
    12
    Tinea versicolour
         subjects affected / exposed
    2 / 183 (1.09%)
    3 / 177 (1.69%)
    9 / 179 (5.03%)
         occurrences all number
    4
    6
    23
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    34 / 183 (18.58%)
    29 / 177 (16.38%)
    41 / 179 (22.91%)
         occurrences all number
    110
    69
    124
    Hyperkalaemia
         subjects affected / exposed
    43 / 183 (23.50%)
    47 / 177 (26.55%)
    44 / 179 (24.58%)
         occurrences all number
    81
    77
    90
    Hypokalaemia
         subjects affected / exposed
    47 / 183 (25.68%)
    40 / 177 (22.60%)
    40 / 179 (22.35%)
         occurrences all number
    104
    88
    102
    Hyperglycaemia
         subjects affected / exposed
    35 / 183 (19.13%)
    29 / 177 (16.38%)
    37 / 179 (20.67%)
         occurrences all number
    76
    81
    80
    Hypocalcaemia
         subjects affected / exposed
    35 / 183 (19.13%)
    37 / 177 (20.90%)
    22 / 179 (12.29%)
         occurrences all number
    61
    68
    43
    Hypophosphataemia
         subjects affected / exposed
    35 / 183 (19.13%)
    34 / 177 (19.21%)
    22 / 179 (12.29%)
         occurrences all number
    70
    60
    56
    Hypercholesterolaemia
         subjects affected / exposed
    21 / 183 (11.48%)
    20 / 177 (11.30%)
    23 / 179 (12.85%)
         occurrences all number
    76
    45
    61
    Hyperuricaemia
         subjects affected / exposed
    16 / 183 (8.74%)
    16 / 177 (9.04%)
    31 / 179 (17.32%)
         occurrences all number
    30
    58
    73
    Hypercalcaemia
         subjects affected / exposed
    24 / 183 (13.11%)
    16 / 177 (9.04%)
    22 / 179 (12.29%)
         occurrences all number
    45
    27
    49
    Hypomagnesaemia
         subjects affected / exposed
    21 / 183 (11.48%)
    14 / 177 (7.91%)
    26 / 179 (14.53%)
         occurrences all number
    44
    20
    52
    Diabetes mellitus
         subjects affected / exposed
    14 / 183 (7.65%)
    18 / 177 (10.17%)
    19 / 179 (10.61%)
         occurrences all number
    27
    35
    38
    Decreased appetite
         subjects affected / exposed
    15 / 183 (8.20%)
    16 / 177 (9.04%)
    17 / 179 (9.50%)
         occurrences all number
    27
    27
    29
    Metabolic acidosis
         subjects affected / exposed
    15 / 183 (8.20%)
    16 / 177 (9.04%)
    16 / 179 (8.94%)
         occurrences all number
    21
    32
    25
    Hyperphosphataemia
         subjects affected / exposed
    16 / 183 (8.74%)
    15 / 177 (8.47%)
    15 / 179 (8.38%)
         occurrences all number
    32
    25
    29
    Acidosis
         subjects affected / exposed
    16 / 183 (8.74%)
    14 / 177 (7.91%)
    15 / 179 (8.38%)
         occurrences all number
    33
    37
    25
    Hyponatraemia
         subjects affected / exposed
    15 / 183 (8.20%)
    13 / 177 (7.34%)
    12 / 179 (6.70%)
         occurrences all number
    29
    24
    21
    Hyperlipidaemia
         subjects affected / exposed
    13 / 183 (7.10%)
    13 / 177 (7.34%)
    13 / 179 (7.26%)
         occurrences all number
    31
    20
    21
    Hypoglycaemia
         subjects affected / exposed
    10 / 183 (5.46%)
    12 / 177 (6.78%)
    13 / 179 (7.26%)
         occurrences all number
    13
    26
    30
    Gout
         subjects affected / exposed
    3 / 183 (1.64%)
    11 / 177 (6.21%)
    7 / 179 (3.91%)
         occurrences all number
    6
    38
    10
    Dehydration
         subjects affected / exposed
    13 / 183 (7.10%)
    10 / 177 (5.65%)
    8 / 179 (4.47%)
         occurrences all number
    18
    17
    12
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 183 (0.55%)
    5 / 177 (2.82%)
    16 / 179 (8.94%)
         occurrences all number
    4
    8
    41
    Fluid overload
         subjects affected / exposed
    11 / 183 (6.01%)
    5 / 177 (2.82%)
    5 / 179 (2.79%)
         occurrences all number
    14
    9
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2005
    Post-transplant steroid tapering schedule was included, exclusion criteria for tuberculosis and mammogram requirements was modified.
    16 Feb 2006
    Month 24 Glomerular Filtration Rate (GFR) test and sample collection for Angiotensin II Type I (AT-1) receptor antibodies was added, administration of the first belatacept infusion on call to the operating room was permitted. Withholding only the morning dose Cyclosporine A prior to the GFR test Safety monitoring was initiated upon randomization prior to transplant.
    29 Oct 2007
    Long-term extension phase, extending the study two years was added, in-line filter manufacturer and specification details were added, serious adverse events reporting contact information and mailing addresses were updated.
    13 Feb 2009
    Surveillance measures for post-transplant lymphoproliferative disorder, safety data from the phase 3 studies, revised risk/benefit assessment, serious breach definition and reporting requirements were added. AT-1 receptor antibody sample collection and ICON Medical Monitor were removed.
    18 Oct 2010
    Added immunogenicity assessments after discontinuation.
    10 Feb 2011
    Updated benefit/risk assessment, added procedures to monitor and better understand post-transplant lymphoproliferative disorder (PTLD) and progressive multifocal leukoencephalopathy (PML), added monitoring guidelines for drug induced liver toxicity (DILI).

    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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