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    Clinical Trial Results:
    A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

    Summary
    EudraCT number
    		 2013-000322-66
    Trial protocol
    		 DE   IT   SK   ES   PT   AT   NL   BE   GR   CZ   SI   BG   PL   HR   NO   SE   FR  
    Global end of trial date
    17 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2018
    First version publication date
    19 Oct 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CRAD001A2433
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01950819
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Novartis Pharma AG, Clinical Disclosure Office, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharma, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective for this trial was to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR <50 mL/min/1.73m2 (estimated glomerular filtration rate by MDRD4 formula) at Month 12 post-transplantation.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 35
    Country: Number of subjects enrolled
    Slovenia: 9
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 159
    Country: Number of subjects enrolled
    Sweden: 38
    Country: Number of subjects enrolled
    Switzerland: 22
    Country: Number of subjects enrolled
    Taiwan: 23
    Country: Number of subjects enrolled
    Thailand: 27
    Country: Number of subjects enrolled
    Turkey: 24
    Country: Number of subjects enrolled
    United States: 352
    Country: Number of subjects enrolled
    Argentina: 77
    Country: Number of subjects enrolled
    Australia: 98
    Country: Number of subjects enrolled
    Austria: 34
    Country: Number of subjects enrolled
    Belgium: 56
    Country: Number of subjects enrolled
    Brazil: 86
    Country: Number of subjects enrolled
    Bulgaria: 12
    Country: Number of subjects enrolled
    Chile: 8
    Country: Number of subjects enrolled
    Colombia: 22
    Country: Number of subjects enrolled
    Croatia: 35
    Country: Number of subjects enrolled
    Czech Republic: 30
    Country: Number of subjects enrolled
    Egypt: 25
    Country: Number of subjects enrolled
    France: 85
    Country: Number of subjects enrolled
    Germany: 168
    Country: Number of subjects enrolled
    Greece: 24
    Country: Number of subjects enrolled
    India: 38
    Country: Number of subjects enrolled
    Israel: 20
    Country: Number of subjects enrolled
    Italy: 94
    Country: Number of subjects enrolled
    Japan: 34
    Country: Number of subjects enrolled
    Korea, Republic of: 53
    Country: Number of subjects enrolled
    Kuwait: 6
    Country: Number of subjects enrolled
    Lebanon: 17
    Country: Number of subjects enrolled
    Malaysia: 5
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Netherlands: 143
    Country: Number of subjects enrolled
    Norway: 15
    Country: Number of subjects enrolled
    Philippines: 29
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    Portugal: 19
    Country: Number of subjects enrolled
    Russian Federation: 47
    Country: Number of subjects enrolled
    Saudi Arabia: 21
    Country: Number of subjects enrolled
    Serbia: 14
    Country: Number of subjects enrolled
    Singapore: 5
    Worldwide total number of subjects
    2037
    EEA total number of subjects
    981
    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)
    1731
    From 65 to 84 years
    306
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The full analysis set consisted of all randomized and transplanted patients. The safet set consisted of all patients who received at least one dose of study drug

    Pre-assignment
    Screening details
    		 2226 patients screened; 2037 patients transplanted and randomized to treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EVR+rCNI
    Arm description
    		 Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Everolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Everolimus was provided as 0.25, 0.5 and 0.75 and 1.0 mg tablets depending on locally approved dosage forms.

    Arm title
    		 MPA+sCNI
    Arm description
    		 Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    mycophenolate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MPA as either mycophenolic acid (sodium) 180 or 360mg enteric-coated tablets or mycophenolate mofetil 250 or 500 mg film coated tablets or 250mg capsules, depending on locally approved dosage forms.

    Number of subjects in period 1
    		EVR+rCNI MPA+sCNI
    Started
    1022
    1015
    Completed
    893
    881
    Not completed
    129
    134
         Adverse event, serious fatal
    29
    34
         technical problems
    2
    -
         Graft Loss
    35
    30
         Pregnancy
    -
    2
         Lost to follow-up
    9
    17
         Subject / Gardian decision
    54
    51

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EVR+rCNI
    Reporting group description
    		 Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

    Reporting group title
    MPA+sCNI
    Reporting group description
    		 Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

    Reporting group values
    		 EVR+rCNI MPA+sCNI Total
    Number of subjects
    		 1022 1015 2037
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 873 858 1731
        From 65-84 years
    		 149 157 306
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.79 ( 14.123 ) 48.75 ( 14.515 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 312 308 620
        Male
    		 710 707 1417
    Race/Ethnicity, Customized
    Ethnicity
    Units: Subjects
        Hispany or Latino|
    		 157 132 289
        not Hispanic or Latino|
    		 646 661 1307
        Unknown or not reported|
    		 102 105 207
        Other
    		 117 117 234
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        Caucasian|
    		 743 735 1478
        Asian|
    		 136 157 293
        Black|
    		 43 35 78
        Other|
    		 100 88 188

    End points

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    End points reporting groups
    Reporting group title
    EVR+rCNI
    Reporting group description
    		 Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

    Reporting group title
    MPA+sCNI
    Reporting group description
    		 Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

    Primary: Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.

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    End point title
    		 Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.
    End point description
    Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.
    End point type
    Primary
    End point timeframe
    Month 12 is Primary, Month 24 secondary
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    489
    456
        month 24|
    489
    443
    Statistical analysis title
    		 Difference between treatments
    Statistical analysis description
    calculated at month 12
    Comparison groups
    EVR+rCNI v MPA+sCNI
    Number of subjects included in analysis
    2037
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.001
    Method
    		 Logistic Regression Model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 7.3
    Notes
    [1] - p vale for non inferiority margin is 10 %

    Secondary: Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death

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    End point title
    		 Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
    End point description
    Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    146
    131
        month 24|
    169
    147
    No statistical analyses for this end point

    Secondary: Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2

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    End point title
    		 Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2
    End point description
    Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    497
    466
        month 24|
    497
    457
    No statistical analyses for this end point

    Secondary: Incidence of failure on the composite endpoint of graft loss or death.

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    End point title
    		 Incidence of failure on the composite endpoint of graft loss or death.
    End point description
    Incidence of failure on the composite endpoint of graft loss or death.
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    51
    54
        month 24|
    67
    65
    No statistical analyses for this end point

    Secondary: Incidence of death, graft loss, tBPAR, BPAR, tAR, AR and humoral rejection

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    End point title
    		 Incidence of death, graft loss, tBPAR, BPAR, tAR, AR and humoral rejection
    End point description
    Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection)
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        deaths month 12|
    20
    28
        deaths month 24|
    32
    36
        graft loss month 12|
    33
    28
        graft loss month 24|
    37
    32
        tBPAR month 12|
    107
    91
        tBPAR month 24|
    118
    98
        BPAR month 12|
    114
    95
        BPAR month 24|
    127
    104
        tAR month 12|
    129
    117
        tAR month 24|
    145
    126
        AR month 12|
    147
    133
        AR month 24|
    167
    144
        aAMR month 12|
    73
    61
        aAMR month 24|
    84
    69
        cAMR month 12|
    9
    14
        cAMR month 24|
    13
    18
    No statistical analyses for this end point

    Secondary: Incidence of eGFR < 50 mL/min/1.73m2

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    End point title
    		 Incidence of eGFR < 50 mL/min/1.73m2
    End point description
    Incidence of eGFR < 50 mL/min/1.73m2
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    456
    424
        month 24|
    474
    423
    No statistical analyses for this end point

    Secondary: Renal allograft function (mean estimated glomerular filtration rate, eGFR)

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    End point title
    		 Renal allograft function (mean estimated glomerular filtration rate, eGFR)
    End point description
    Renal allograft function (mean estimated glomerular filtration rate, eGFR)
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: mL/min/1.73m2
    arithmetic mean (standard error)
        baseline (week 4)|
    53.13 ( 0.765 )
    52.25 ( 0.684 )
        month 12|
    53.29 ( 0.698 )
    54.49 ( 0.667 )
        month 24|
    52.63 ( 0.744 )
    54.91 ( 0.719 )
    No statistical analyses for this end point

    Secondary: Evolution of renal function, as eGFR, over time by slope analysis.

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    End point title
    		 Evolution of renal function, as eGFR, over time by slope analysis.
    End point description
    Rate of change of renal function, as eGFR, over time by slope analysis.
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: mL/min/1.73m2
    arithmetic mean (standard error)
        slope of eGFR|
    0.0001 ( 0.0008 )
    0.0047 ( 0.0008 )
        eGFR at month 12|
    55.32 ( 0.68 )
    57.44 ( 0.67 )
        eGFR at month 24|
    55.43 ( 0.60 )
    57.28 ( 0.60 )
    No statistical analyses for this end point

    Secondary: Renal function by Cystatin C-based and other alternate formulae (e.g. CKD-EPI).

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    End point title
    		 Renal function by Cystatin C-based and other alternate formulae (e.g. CKD-EPI).
    End point description
    Mean Renal function by eGFR or ceatinine clearance Cystatin C-based and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis.
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: micromol/L; mL/min/1.73m2
    arithmetic mean (standard deviation)
        screening baseline (creatinine, micromol/L)|
    590.1 ( 262.78 )
    601.8 ( 265.08 )
        month 12 (creatinine, micromol/L)|
    129.8 ( 49.12 )
    128.6 ( 50.80 )
        month 24 (creatinine, micromol/L)|
    130.1 ( 53.54 )
    127.6 ( 52.50 )
        eGFR (Hoek) baseline (mL/min/1.73m2)|
    21.38 ( 14.296 )
    20.10 ( 12.408 )
        eGFR (Hoek) month 12 (mL/min/1.73m2)|
    50.08 ( 14.430 )
    52.00 ( 14.533 )
        eGFR (Hoek) month 24 (mL/min/1.73m2)|
    49.86 ( 14.604 )
    52.75 ( 15.406 )
        eGFR (MDRD4) baseline (mL/min/1.73m2)|
    11.79 ( 8.697 )
    11.56 ( 8.853 )
        eGFR (MDRD4) month 12 (mL/min/1.73m2)|
    57.59 ( 19.685 )
    57.58 ( 18.768 )
        eGFR (MDRD4) month 24 (mL/min/1.73m2)|
    58.07 ( 20.168 )
    58.68 ( 19.541 )
        eGFR-CKDEPI baseline (mL/min/1.73m2)|
    11.29 ( 9.094 )
    11.05 ( 9.195 )
        eGFR-CKDEPI month 12(mL/min/1.73m2)|
    58.83 ( 20.686 )
    58.75 ( 19.757 )
        eGFR-CKDEPI month 24 (mL/min/1.73m2)|
    59.39 ( 21.077 )
    59.95 ( 20.652 )
    No statistical analyses for this end point

    Secondary: Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.

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    End point title
    		 Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.
    End point description
    Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1014
    1012
    Units: participants
    276
    152
    No statistical analyses for this end point

    Secondary: Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.

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    End point title
    		 Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.
    End point description
    Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1014
    1012
    Units: participants
        clinical signs of CMV infection|
    53
    132
        any BKV infection|
    103
    154
        new onset of diabetes mellitus|
    144
    138
        at least one event of interest|
    871
    764
    No statistical analyses for this end point

    Secondary: Urinary protein and albumin excretion by treatment estimated by urinary protein/creatinine and urinary albumin/creatinine ratios.

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    End point title
    		 Urinary protein and albumin excretion by treatment estimated by urinary protein/creatinine and urinary albumin/creatinine ratios.
    End point description
    Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1014
    1012
    Units: mg/g
    arithmetic mean (standard deviation)
        albumine /creatinine ratio baseline|
    1019.75 ( 2737.96 )
    646.111 ( 799.234 )
        albumine /creatinine ratio month 12|
    150.061 ( 482.394 )
    111.322 ( 444.631 )
        albumine /creatinine ratio month 24|
    149.049 ( 464.470 )
    116.618 ( 433.392 )
        protein /creatinine ratio baseline|
    1648.10 ( 3768.22 )
    1142.59 ( 1003.69 )
        protein /creatinine ratio month 12|
    298.557 ( 642.103 )
    234.698 ( 583.632 )
        protein /creatinine ratio month 24|
    290.242 ( 588.119 )
    233.009 ( 524.383 )
    No statistical analyses for this end point

    Secondary: Incidence of major cardiovascular events.

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    End point title
    		 Incidence of major cardiovascular events.
    End point description
    Incidence of major cardiovascular events by Preferred Term
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1014
    1012
    Units: participants
    66
    86
    No statistical analyses for this end point

    Secondary: Incidence of malignancies.

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    End point title
    		 Incidence of malignancies.
    End point description
    Incidence of malignancies.
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1014
    1012
    Units: participants
    41
    39
    No statistical analyses for this end point

    Secondary: Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects.

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    End point title
    		 Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects.
    End point description
    Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects.
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    187
    277
    Units: participants
        month 12|
    60
    106
        month 24|
    62
    102
    No statistical analyses for this end point

    Secondary: Incidence tBPAR by severity and time to event

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    End point title
    		 Incidence tBPAR by severity and time to event
    End point description
    Incidence tBPAR by severity and time to event
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        no grade (missing)|
    25
    18
        Patient's maximum tBPAR grade IA|
    34
    36
        Patient's maximum tBPAR grade IB|
    23
    17
        Patient's maximum tBPAR grade IIA|
    21
    24
        Patient's maximum tBPAR grade IIB|
    9
    3
        Patient's maximum tBPAR grade III|
    6
    0
        overall number of tBPAR regardless of grade|
    146
    116
        number of tBPAR regardless of grade days 1-90|
    72
    63
        number of tBPAR regardless of grade days 91-180|
    24
    14
        number of tBPAR regardless of grade days 181-360|
    25
    20
        number of tBPAR regardless of grade days 361-540|
    12
    15
        number of tBPAR regardless of grade days 541-720|
    11
    2
        number of tBPAR regardless of grade days 721-810|
    2
    2
    No statistical analyses for this end point

    Secondary: Incidence of tBPAR excluding grade IA rejections

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    End point title
    		 Incidence of tBPAR excluding grade IA rejections
    End point description
    Incidence of tBPAR excluding grade IA rejections
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    66
    53
        month 24|
    74
    55
    No statistical analyses for this end point

    Secondary: Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup

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    End point title
    		 Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup
    End point description
    Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    489
    456
        month 24|
    489
    443
    No statistical analyses for this end point

    Secondary: Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2

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    End point title
    		 Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2
    End point description
    Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    475
    441
        month 24|
    475
    426
    No statistical analyses for this end point

    Secondary: Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up

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    End point title
    		 Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up
    End point description
    Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up
    End point type
    Secondary
    End point timeframe
    Month 12 and 24
    End point values
    		 EVR+rCNI MPA+sCNI
    Number of subjects analysed
    1022
    1015
    Units: participants
        month 12|
    181
    170
        month 24|
    218
    201
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    MPA plus standard@CNI
    Reporting group description
    		 MPA plus standard@CNI

    Reporting group title
    Everolimus plus@reduced CNI
    Reporting group description
    		 Everolimus plus@reduced CNI

    Serious adverse events
    		 MPA plus standard@CNI Everolimus plus@reduced CNI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    613 / 1012 (60.57%)
    593 / 1014 (58.48%)
         number of deaths (all causes)
    29
    20
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    4 / 1012 (0.40%)
    10 / 1014 (0.99%)
         occurrences causally related to treatment / all
    4 / 5
    8 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastrointestinal neoplasm
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign pancreatic neoplasm
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer
         subjects affected / exposed
    3 / 1012 (0.30%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchioloalveolar carcinoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral haemangioma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus associated lymphoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Leydig cell tumour of the testis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoproliferative disorder
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of pleura metastatic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to bone
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to spine
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoclonal gammopathy
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary tumour of renal pelvis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    4 / 1012 (0.40%)
    8 / 1014 (0.79%)
         occurrences causally related to treatment / all
    5 / 5
    5 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    5 / 1012 (0.49%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Testicular neoplasm
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour of ampulla of Vater
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic perforation
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Artery dissection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    12 / 1012 (1.19%)
    20 / 1014 (1.97%)
         occurrences causally related to treatment / all
    2 / 14
    9 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    6 / 1012 (0.59%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    5 / 1012 (0.49%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    8 / 1012 (0.79%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    21 / 1012 (2.08%)
    34 / 1014 (3.35%)
         occurrences causally related to treatment / all
    4 / 22
    18 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphorrhoea
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arteriovenous fistula operation
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchidectomy
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Cephalhaematoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait inability
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ill-defined disorder
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 1012 (0.10%)
    10 / 1014 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    10 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site discomfort
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site inflammation
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microlithiasis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    4 / 1012 (0.40%)
    7 / 1014 (0.69%)
         occurrences causally related to treatment / all
    0 / 4
    5 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    36 / 1012 (3.56%)
    35 / 1014 (3.45%)
         occurrences causally related to treatment / all
    13 / 40
    16 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Suprapubic pain
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic allograft nephropathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunosuppression
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney transplant rejection
         subjects affected / exposed
    17 / 1012 (1.68%)
    18 / 1014 (1.78%)
         occurrences causally related to treatment / all
    9 / 19
    8 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    5 / 1012 (0.49%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    25 / 1012 (2.47%)
    45 / 1014 (4.44%)
         occurrences causally related to treatment / all
    7 / 27
    16 / 49
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Loss of personal independence in daily activities
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Walking disability
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Menorrhagia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    4 / 1012 (0.40%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal oedema
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular oedema
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    4 / 1012 (0.40%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    7 / 1012 (0.69%)
    8 / 1014 (0.79%)
         occurrences causally related to treatment / all
    1 / 8
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    6 / 1012 (0.59%)
    17 / 1014 (1.68%)
         occurrences causally related to treatment / all
    1 / 6
    6 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary hypertension
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 1012 (0.20%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    4 / 1012 (0.40%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device leakage
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perforation bile duct
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy kidney
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine increased
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine abnormal
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    36 / 1012 (3.56%)
    50 / 1014 (4.93%)
         occurrences causally related to treatment / all
    6 / 44
    18 / 63
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urea increased
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction abnormal
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haptoglobin decreased
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunosuppressant drug level increased
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory marker increased
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Norovirus test positive
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occult blood positive
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyomavirus test positive
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine output decreased
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaesthetic complication
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aponeurosis contusion
         subjects affected / exposed
    3 / 1012 (0.30%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula aneurysm
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site complication
         subjects affected / exposed
    4 / 1012 (0.40%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Avulsion fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplant surgery
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    28 / 1012 (2.77%)
    34 / 1014 (3.35%)
         occurrences causally related to treatment / all
    3 / 32
    9 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary bypass stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed graft function
         subjects affected / exposed
    2 / 1012 (0.20%)
    7 / 1014 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft complication
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft haemorrhage
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft loss
         subjects affected / exposed
    12 / 1012 (1.19%)
    16 / 1014 (1.58%)
         occurrences causally related to treatment / all
    2 / 12
    3 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site complication
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 1012 (0.10%)
    8 / 1014 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal injury
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    3 / 1012 (0.30%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial reocclusion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirenal haematoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural discharge
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    4 / 1012 (0.40%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural persistent drain fluid
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural urine leak
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative fever
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative hernia
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal lymphocele
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant torsion
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal haematoma
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    2 / 1012 (0.20%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt aneurysm
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt stenosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    4 / 1012 (0.40%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant dysfunction
         subjects affected / exposed
    7 / 1012 (0.69%)
    7 / 1014 (0.69%)
         occurrences causally related to treatment / all
    2 / 8
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant failure
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplantation complication
         subjects affected / exposed
    1 / 1012 (0.10%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric anastomosis complication
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary anastomotic leak
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaccination complication
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound decomposition
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    3 / 1012 (0.30%)
    10 / 1014 (0.99%)
         occurrences causally related to treatment / all
    0 / 3
    7 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound secretion
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous malformation
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital cystic kidney disease
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital megaureter
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheo-oesophageal fistula
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    2 / 1012 (0.20%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    6 / 1012 (0.59%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    5 / 1012 (0.49%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    12 / 1012 (1.19%)
    12 / 1014 (1.18%)
         occurrences causally related to treatment / all
    2 / 15
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 1012 (0.10%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    4 / 1012 (0.40%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Cardiac asthma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac dysfunction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    7 / 1012 (0.69%)
    9 / 1014 (0.89%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    3 / 1012 (0.30%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiorenal syndrome
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    6 / 1012 (0.59%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    6 / 1012 (0.59%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Myocardial ischaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis constrictive
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachyarrhythmia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune encephalopathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain stem infarction
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system lesion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    7 / 1012 (0.69%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    3 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemic seizure
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelitis transverse
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transverse sinus thrombosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual field defect
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    6 / 1012 (0.59%)
    14 / 1014 (1.38%)
         occurrences causally related to treatment / all
    2 / 9
    6 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical haemolytic uraemic syndrome
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    5 / 1012 (0.49%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulocytopenia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    12 / 1012 (1.19%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    10 / 14
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic obstruction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    6 / 1012 (0.59%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    4 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenomegaly
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    3 / 1012 (0.30%)
    8 / 1014 (0.79%)
         occurrences causally related to treatment / all
    2 / 3
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Mastoid effusion
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    2 / 1012 (0.20%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    14 / 1012 (1.38%)
    9 / 1014 (0.89%)
         occurrences causally related to treatment / all
    5 / 18
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    3 / 1012 (0.30%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal polyp
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital dysplasia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colitis ulcerative
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroparesis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    55 / 1012 (5.43%)
    27 / 1014 (2.66%)
         occurrences causally related to treatment / all
    32 / 60
    9 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encapsulating peritoneal sclerosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal fistula
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    4 / 1012 (0.40%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial eventration
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 1012 (0.20%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    5 / 1012 (0.49%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 1012 (0.10%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar hernia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    9 / 1012 (0.89%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    3 / 11
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal spasm
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retching
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    5 / 1012 (0.49%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland enlargement
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    4 / 1012 (0.40%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus of small bowel
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    13 / 1012 (1.28%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    5 / 18
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Capillaritis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic ulcer
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peau d'orange
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin oedema
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    37 / 1012 (3.66%)
    46 / 1014 (4.54%)
         occurrences causally related to treatment / all
    12 / 47
    10 / 50
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anuria
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neck obstruction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder obstruction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder perforation
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dysuria
         subjects affected / exposed
    5 / 1012 (0.49%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis chronic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis membranoproliferative
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis membranous
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosuria
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    14 / 1012 (1.38%)
    9 / 1014 (0.89%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    6 / 1012 (0.59%)
    9 / 1014 (0.89%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydroureter
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonic bladder
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IgM nephropathy
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic nephropathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocyturia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesangioproliferative glomerulonephritis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive nephropathy
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephric collection
         subjects affected / exposed
    5 / 1012 (0.49%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    3 / 1012 (0.30%)
    15 / 1014 (1.48%)
         occurrences causally related to treatment / all
    0 / 4
    10 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocaliectasis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery dissection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery occlusion
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    7 / 1012 (0.69%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cortical necrosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst haemorrhage
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst ruptured
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    25 / 1012 (2.47%)
    23 / 1014 (2.27%)
         occurrences causally related to treatment / all
    7 / 26
    11 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal ischaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal necrosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular atrophy
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    5 / 1012 (0.49%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal vein thrombosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric dilatation
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    6 / 1012 (0.59%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urge incontinence
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary fistula
         subjects affected / exposed
    2 / 1012 (0.20%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 1012 (0.10%)
    9 / 1014 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    8 / 1012 (0.79%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    4 / 1012 (0.40%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinoma
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism tertiary
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 1012 (0.10%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc space narrowing
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia intercostal
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 1012 (0.20%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    9 / 1014 (0.89%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubic pain
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Actinomycosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoviral haemorrhagic cystitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 1012 (0.30%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    BK virus infection
         subjects affected / exposed
    5 / 1012 (0.49%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    3 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteriuria
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blister infected
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 1012 (0.30%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Candiduria
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    6 / 1012 (0.59%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall abscess
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    3 / 1012 (0.30%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptococcosis
         subjects affected / exposed
    3 / 1012 (0.30%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis viral
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    9 / 1012 (0.89%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    5 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus enteritis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus gastroenteritis
         subjects affected / exposed
    3 / 1012 (0.30%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus gastrointestinal infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus hepatitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    48 / 1012 (4.74%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    40 / 55
    6 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatophytosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    3 / 1012 (0.30%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endocarditis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 1012 (0.10%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    7 / 1012 (0.69%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    4 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal sepsis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    23 / 1012 (2.27%)
    18 / 1014 (1.78%)
         occurrences causally related to treatment / all
    8 / 25
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis cryptosporidial
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    6 / 1012 (0.59%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    2 / 1012 (0.20%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIV infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis viral
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex pneumonia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    4 / 1012 (0.40%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal gangrene
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    1 / 1012 (0.10%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected seroma
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    2 / 1012 (0.20%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    5 / 1012 (0.49%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal sepsis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site cellulitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis cryptococcal
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nocardiosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    5 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 1012 (0.20%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parvovirus B19 infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephric abscess
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    3 / 1012 (0.30%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    2 / 3
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    36 / 1012 (3.56%)
    55 / 1014 (5.42%)
         occurrences causally related to treatment / all
    18 / 41
    31 / 63
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia cryptococcal
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    4 / 1012 (0.40%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumonia fungal
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    10 / 1012 (0.99%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    10 / 10
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    3 / 1012 (0.30%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    33 / 1012 (3.26%)
    24 / 1014 (2.37%)
         occurrences causally related to treatment / all
    15 / 40
    15 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    13 / 1012 (1.28%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    8 / 19
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyuria
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst infection
         subjects affected / exposed
    3 / 1012 (0.30%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal graft infection
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    5 / 1012 (0.49%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    2 / 5
    2 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory tract infection fungal
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    7 / 1012 (0.69%)
    20 / 1014 (1.97%)
         occurrences causally related to treatment / all
    4 / 7
    9 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Septic shock
         subjects affected / exposed
    8 / 1012 (0.79%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    3 / 9
    2 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Sinusitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis fungal
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 1012 (0.00%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant abscess
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis gastrointestinal
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 1012 (0.40%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    3 / 5
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    93 / 1012 (9.19%)
    78 / 1014 (7.69%)
         occurrences causally related to treatment / all
    49 / 124
    37 / 110
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 1012 (0.10%)
    4 / 1014 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    23 / 1012 (2.27%)
    23 / 1014 (2.27%)
         occurrences causally related to treatment / all
    14 / 28
    9 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral myocarditis
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound abscess
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    4 / 1012 (0.40%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    2 / 1012 (0.20%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calciphylaxis
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    2 / 1012 (0.20%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    11 / 1012 (1.09%)
    6 / 1014 (0.59%)
         occurrences causally related to treatment / all
    2 / 11
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    10 / 1012 (0.99%)
    9 / 1014 (0.89%)
         occurrences causally related to treatment / all
    5 / 10
    6 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 1012 (0.20%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 1012 (0.20%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    3 / 1012 (0.30%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    0 / 3
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 1012 (0.10%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    6 / 1012 (0.59%)
    5 / 1014 (0.49%)
         occurrences causally related to treatment / all
    4 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    10 / 1012 (0.99%)
    11 / 1014 (1.08%)
         occurrences causally related to treatment / all
    2 / 11
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 1012 (0.00%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    2 / 1014 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    5 / 1012 (0.49%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 1012 (0.00%)
    3 / 1014 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    5 / 1012 (0.49%)
    1 / 1014 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    4 / 1012 (0.40%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 1012 (0.10%)
    0 / 1014 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MPA plus standard@CNI Everolimus plus@reduced CNI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    942 / 1012 (93.08%)
    951 / 1014 (93.79%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    230 / 1012 (22.73%)
    240 / 1014 (23.67%)
         occurrences all number
    264
    275
    Hypotension
         subjects affected / exposed
    78 / 1012 (7.71%)
    62 / 1014 (6.11%)
         occurrences all number
    83
    67
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    64 / 1012 (6.32%)
    59 / 1014 (5.82%)
         occurrences all number
    77
    63
    Oedema peripheral
         subjects affected / exposed
    244 / 1012 (24.11%)
    347 / 1014 (34.22%)
         occurrences all number
    339
    512
    Pyrexia
         subjects affected / exposed
    132 / 1012 (13.04%)
    112 / 1014 (11.05%)
         occurrences all number
    162
    130
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    102 / 1012 (10.08%)
    86 / 1014 (8.48%)
         occurrences all number
    110
    100
    Dyspnoea
         subjects affected / exposed
    70 / 1012 (6.92%)
    73 / 1014 (7.20%)
         occurrences all number
    85
    84
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    59 / 1012 (5.83%)
    51 / 1014 (5.03%)
         occurrences all number
    66
    57
    Insomnia
         subjects affected / exposed
    138 / 1012 (13.64%)
    100 / 1014 (9.86%)
         occurrences all number
    155
    113
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    133 / 1012 (13.14%)
    141 / 1014 (13.91%)
         occurrences all number
    160
    167
    Weight increased
         subjects affected / exposed
    66 / 1012 (6.52%)
    38 / 1014 (3.75%)
         occurrences all number
    67
    39
    Injury, poisoning and procedural complications
    Complications of transplanted kidney
         subjects affected / exposed
    54 / 1012 (5.34%)
    63 / 1014 (6.21%)
         occurrences all number
    65
    67
    Incision site pain
         subjects affected / exposed
    61 / 1012 (6.03%)
    51 / 1014 (5.03%)
         occurrences all number
    65
    55
    Procedural pain
         subjects affected / exposed
    99 / 1012 (9.78%)
    90 / 1014 (8.88%)
         occurrences all number
    117
    100
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    52 / 1012 (5.14%)
    53 / 1014 (5.23%)
         occurrences all number
    59
    62
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    54 / 1012 (5.34%)
    51 / 1014 (5.03%)
         occurrences all number
    62
    58
    Headache
         subjects affected / exposed
    113 / 1012 (11.17%)
    133 / 1014 (13.12%)
         occurrences all number
    144
    172
    Tremor
         subjects affected / exposed
    145 / 1012 (14.33%)
    100 / 1014 (9.86%)
         occurrences all number
    161
    103
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    238 / 1012 (23.52%)
    227 / 1014 (22.39%)
         occurrences all number
    267
    260
    Leukocytosis
         subjects affected / exposed
    58 / 1012 (5.73%)
    24 / 1014 (2.37%)
         occurrences all number
    59
    26
    Leukopenia
         subjects affected / exposed
    194 / 1012 (19.17%)
    94 / 1014 (9.27%)
         occurrences all number
    234
    108
    Polycythaemia
         subjects affected / exposed
    42 / 1012 (4.15%)
    52 / 1014 (5.13%)
         occurrences all number
    44
    58
    Thrombocytopenia
         subjects affected / exposed
    41 / 1012 (4.05%)
    74 / 1014 (7.30%)
         occurrences all number
    45
    85
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    104 / 1012 (10.28%)
    94 / 1014 (9.27%)
         occurrences all number
    126
    107
    Abdominal pain upper
         subjects affected / exposed
    62 / 1012 (6.13%)
    39 / 1014 (3.85%)
         occurrences all number
    69
    45
    Constipation
         subjects affected / exposed
    242 / 1012 (23.91%)
    245 / 1014 (24.16%)
         occurrences all number
    286
    282
    Diarrhoea
         subjects affected / exposed
    318 / 1012 (31.42%)
    242 / 1014 (23.87%)
         occurrences all number
    437
    315
    Nausea
         subjects affected / exposed
    225 / 1012 (22.23%)
    191 / 1014 (18.84%)
         occurrences all number
    271
    238
    Vomiting
         subjects affected / exposed
    140 / 1012 (13.83%)
    120 / 1014 (11.83%)
         occurrences all number
    172
    144
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    37 / 1012 (3.66%)
    56 / 1014 (5.52%)
         occurrences all number
    39
    58
    Alopecia
         subjects affected / exposed
    59 / 1012 (5.83%)
    27 / 1014 (2.66%)
         occurrences all number
    59
    28
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    74 / 1012 (7.31%)
    60 / 1014 (5.92%)
         occurrences all number
    78
    66
    Haematuria
         subjects affected / exposed
    101 / 1012 (9.98%)
    102 / 1014 (10.06%)
         occurrences all number
    110
    117
    Proteinuria
         subjects affected / exposed
    69 / 1012 (6.82%)
    131 / 1014 (12.92%)
         occurrences all number
    80
    145
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    65 / 1012 (6.42%)
    63 / 1014 (6.21%)
         occurrences all number
    74
    72
    Back pain
         subjects affected / exposed
    98 / 1012 (9.68%)
    93 / 1014 (9.17%)
         occurrences all number
    106
    103
    Pain in extremity
         subjects affected / exposed
    61 / 1012 (6.03%)
    66 / 1014 (6.51%)
         occurrences all number
    68
    77
    Infections and infestations
    BK virus infection
         subjects affected / exposed
    101 / 1012 (9.98%)
    56 / 1014 (5.52%)
         occurrences all number
    118
    68
    Cytomegalovirus infection
         subjects affected / exposed
    93 / 1012 (9.19%)
    24 / 1014 (2.37%)
         occurrences all number
    107
    26
    Nasopharyngitis
         subjects affected / exposed
    117 / 1012 (11.56%)
    110 / 1014 (10.85%)
         occurrences all number
    152
    135
    Upper respiratory tract infection
         subjects affected / exposed
    102 / 1012 (10.08%)
    81 / 1014 (7.99%)
         occurrences all number
    125
    95
    Urinary tract infection
         subjects affected / exposed
    249 / 1012 (24.60%)
    219 / 1014 (21.60%)
         occurrences all number
    471
    373
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    120 / 1012 (11.86%)
    133 / 1014 (13.12%)
         occurrences all number
    126
    136
    Dyslipidaemia
         subjects affected / exposed
    57 / 1012 (5.63%)
    98 / 1014 (9.66%)
         occurrences all number
    59
    104
    Hypercalcaemia
         subjects affected / exposed
    67 / 1012 (6.62%)
    39 / 1014 (3.85%)
         occurrences all number
    74
    42
    Hypercholesterolaemia
         subjects affected / exposed
    61 / 1012 (6.03%)
    103 / 1014 (10.16%)
         occurrences all number
    63
    110
    Hyperglycaemia
         subjects affected / exposed
    144 / 1012 (14.23%)
    140 / 1014 (13.81%)
         occurrences all number
    162
    155
    Hyperkalaemia
         subjects affected / exposed
    184 / 1012 (18.18%)
    164 / 1014 (16.17%)
         occurrences all number
    230
    192
    Hyperlipidaemia
         subjects affected / exposed
    75 / 1012 (7.41%)
    135 / 1014 (13.31%)
         occurrences all number
    77
    140
    Hypertriglyceridaemia
         subjects affected / exposed
    24 / 1012 (2.37%)
    58 / 1014 (5.72%)
         occurrences all number
    25
    63
    Hyperuricaemia
         subjects affected / exposed
    64 / 1012 (6.32%)
    49 / 1014 (4.83%)
         occurrences all number
    69
    55
    Hypocalcaemia
         subjects affected / exposed
    98 / 1012 (9.68%)
    109 / 1014 (10.75%)
         occurrences all number
    106
    118
    Hypokalaemia
         subjects affected / exposed
    87 / 1012 (8.60%)
    148 / 1014 (14.60%)
         occurrences all number
    108
    180
    Hypomagnesaemia
         subjects affected / exposed
    168 / 1012 (16.60%)
    134 / 1014 (13.21%)
         occurrences all number
    190
    153
    Hypophosphataemia
         subjects affected / exposed
    167 / 1012 (16.50%)
    190 / 1014 (18.74%)
         occurrences all number
    178
    210
    Metabolic acidosis
         subjects affected / exposed
    98 / 1012 (9.68%)
    77 / 1014 (7.59%)
         occurrences all number
    109
    93
    Vitamin D deficiency
         subjects affected / exposed
    57 / 1012 (5.63%)
    53 / 1014 (5.23%)
         occurrences all number
    58
    54

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2016
    In response to the French Health Authorities (HA) request, the protocol was updated with the recent notifications for use of mycophenolate based on European Medicines Agency’s (EMA) recommendation published on 23-Oct-2015, and the Dear Health Care Professional Letter (DHCPL) for CellCept that was distributed by Roche by 10-Nov-2015. Mycophenolate (mycophenolate mofetil or mycophenolic acid) is a confirmed teratogen associated with an increased rate of spontaneous abortion and congenital malformation compared with other immunosuppressants. Therefore, investigators should ensure that female and male patients taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult responsible investigator if there is a possibility of pregnancy or a suspected gap of contraception.

    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.
    NA
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