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    Clinical Trial Results:
    A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

    Summary
    EudraCT number
    2006-005687-44
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    21 May 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    30 May 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0468H1-316
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00038948
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Alias: B1741186
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Dec 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of conversion from calcineurin inhibitor (CNI)- to sirolimus (SRL)-based therapy on renal function 52 weeks after randomization, as indicated by the change from baseline calculated glomerular filtration rate (GFR) (Nankivell method), and to demonstrate: a)superiority of the SRL conversion versus CNI continuation regimens in subjects with baseline Nankivell GFRs greater than (>) 40 milliliter per minute (mL/min). OR b)noninferiority of the SRL conversion versus CNI continuation regimens in subjects with baseline Nankivell GFRs of 20 to 40 mL/min, and to establish superiority in this group if the results are consistent with this conclusion. To assess equivalence 52 weeks after randomization between treatment groups in the composite endpoint of the incidence of the first occurrence of biopsy-confirmed acute rejection, graft loss, or death.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Feb 2002
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 31
    Country: Number of subjects enrolled
    Spain: 59
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United States: 176
    Country: Number of subjects enrolled
    Argentina: 68
    Country: Number of subjects enrolled
    Australia: 38
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Brazil: 80
    Country: Number of subjects enrolled
    Canada: 37
    Country: Number of subjects enrolled
    Chile: 9
    Country: Number of subjects enrolled
    Czech Republic: 33
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Italy: 46
    Country: Number of subjects enrolled
    Mexico: 126
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Portugal: 21
    Country: Number of subjects enrolled
    Saudi Arabia: 2
    Country: Number of subjects enrolled
    Singapore: 7
    Worldwide total number of subjects
    830
    EEA total number of subjects
    256
    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)
    38
    Adults (18-64 years)
    751
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited worldwide from January 2002 to September 2003.

    Pre-assignment
    Screening details
    Subjects were screened for two weeks.

    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
    SRL Conversion in Stable Renal Transplant Recipients
    Arm description
    Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
    Arm type
    Experimental

    Investigational medicinal product name
    Sirolimus
    Investigational medicinal product code
    Other name
    Rapamune
    Pharmaceutical forms
    Oral solution, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SRL was concentration-controlled and adjusted to achieve a whole blood trough level in the range of 8 to 20 nanogram per milliliter (ng/mL). SRL was administered for the entire 208-weeks treatment period.

    Arm title
    CNI Continuation in Stable Renal Transplant Recipients
    Arm description
    Continued calcineurin inhibitor immunosuppression therapy. Subjects in this arm will receive either CsA or TAC.
    Arm type
    Active comparator

    Investigational medicinal product name
    Cyclosporine (cyclosporin A):CsA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    CsA trough concentrations was monitored at designated intervals and the CsA dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL. Subjects continue to receive CsA for the entire 208-week treatment period. The investigators supplied CNIs in the appropriate formulation available in their region.

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Tacrolimus (TAC) trough concentrations was monitored at designated intervals and the TAC dose adjusted to maintain the following trough concentration ranges: TAC 4-10 ng/mL. Subjects continue to receive tacrolimus for the entire 208-week treatment period. The investigators supplied TAC in the appropriate formulation available in their region.

    Number of subjects in period 1
    SRL Conversion in Stable Renal Transplant Recipients CNI Continuation in Stable Renal Transplant Recipients
    Started
    555
    275
    Completed
    441
    222
    Not completed
    114
    53
         Adverse event
    19
    6
         No longer willing to participate in study
    31
    19
         Lost to follow-up
    35
    18
         Subject Died
    25
    8
         Randomized, but not treated
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SRL Conversion in Stable Renal Transplant Recipients
    Reporting group description
    Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.

    Reporting group title
    CNI Continuation in Stable Renal Transplant Recipients
    Reporting group description
    Continued calcineurin inhibitor immunosuppression therapy. Subjects in this arm will receive either CsA or TAC.

    Reporting group values
    SRL Conversion in Stable Renal Transplant Recipients CNI Continuation in Stable Renal Transplant Recipients Total
    Number of subjects
    555 275 830
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    45 (13.2 to 75.1) 43.5 (12.8 to 74) -
    Gender categorical
    Units: Subjects
        Female
    170 81 251
        Male
    385 194 579

    End points

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    End points reporting groups
    Reporting group title
    SRL Conversion in Stable Renal Transplant Recipients
    Reporting group description
    Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.

    Reporting group title
    CNI Continuation in Stable Renal Transplant Recipients
    Reporting group description
    Continued calcineurin inhibitor immunosuppression therapy. Subjects in this arm will receive either CsA or TAC.

    Subject analysis set title
    SRL Conversion Strata 20.0-40.0 milliliter/minute (mL/Min)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients.

    Subject analysis set title
    CNI Continuation Strata 20.0-40.0 mL/Min
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.

    Subject analysis set title
    SRL Conversion Strata >40.0 mL/Min
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.

    Subject analysis set title
    CNI Continuation Strata >40.0 mL/Min
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.

    Primary: Nankivell Glomerular Filtration Rate (GFR) at Week 52

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    End point title
    Nankivell Glomerular Filtration Rate (GFR) at Week 52
    End point description
    Nankivell GFR: subjects with baseline GFR of 20.0 to 40.0 mL/min and subjects with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function. Subjects were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min. Arithmetic mean as from ANCOVA model adjusted for center and baseline.
    End point type
    Primary
    End point timeframe
    52 weeks
    End point values
    SRL Conversion Strata 20.0-40.0 milliliter/minute (mL/Min) CNI Continuation Strata 20.0-40.0 mL/Min SRL Conversion Strata >40.0 mL/Min CNI Continuation Strata >40.0 mL/Min
    Number of subjects analysed
    58
    29
    496
    245
    Units: mL/min
        arithmetic mean (standard error)
    24.56 ± 2.42
    27.24 ± 3.71
    59.04 ± 0.89
    57.73 ± 1.1
    Statistical analysis title
    Baseline GFR of 20.0 to 40.0 mL/min
    Statistical analysis description
    Data was adjusted for baseline and center.
    Comparison groups
    SRL Conversion Strata 20.0-40.0 milliliter/minute (mL/Min) v CNI Continuation Strata 20.0-40.0 mL/Min
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.575 [1]
    Method
    ANCOVA
    Parameter type
    Weighted difference
    Point estimate
    -2.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.27
         upper limit
    6.91
    Notes
    [1] - Analysis of covariance P-value for testing the equality of mean GFR at week 52 between treatments.
    Statistical analysis title
    Baseline GFR of >40.0 mL/min
    Statistical analysis description
    Data was adjusted for baseline and center.
    Comparison groups
    CNI Continuation Strata >40.0 mL/Min v SRL Conversion Strata >40.0 mL/Min
    Number of subjects included in analysis
    741
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.278 [2]
    Method
    ANCOVA
    Parameter type
    Weighted difference
    Point estimate
    1.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.06
         upper limit
    3.69
    Notes
    [2] - Analysis of covariance P-value for testing the equality of mean GFR at week 52 between treatments.

    Primary: First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death

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    End point title
    First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death
    End point description
    Number of subjects who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined). Subjects were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min. The outcome measure was primary safety endpoint.
    End point type
    Primary
    End point timeframe
    52 and 104 weeks
    End point values
    SRL Conversion Strata 20.0-40.0 milliliter/minute (mL/Min) CNI Continuation Strata 20.0-40.0 mL/Min SRL Conversion Strata >40.0 mL/Min CNI Continuation Strata >40.0 mL/Min
    Number of subjects analysed
    58
    29
    497
    246
    Units: subjects
        52 weeks - Acute rejection
    4
    0
    8
    3
        52 weeks - Graft loss
    7
    3
    3
    3
        52 weeks - Death
    3
    0
    6
    1
        52 weeks - Missing
    0
    0
    5
    1
        104 weeks - Acute rejection
    5
    1
    27
    9
        104 weeks - Graft loss
    12
    9
    12
    8
        104 weeks - Death
    7
    0
    13
    3
        104 weeks - Missing
    0
    2
    13
    8
    Statistical analysis title
    52 Weeks Statistical Analysis Across Strata
    Comparison groups
    SRL Conversion Strata 20.0-40.0 milliliter/minute (mL/Min) v CNI Continuation Strata 20.0-40.0 mL/Min v SRL Conversion Strata >40.0 mL/Min v CNI Continuation Strata >40.0 mL/Min
    Number of subjects included in analysis
    830
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.135 [3]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - P-value for testing the equality of rates between treatments across strata at 52 weeks.
    Statistical analysis title
    104 Weeks Statistical Analysis Across Strata
    Comparison groups
    SRL Conversion Strata 20.0-40.0 milliliter/minute (mL/Min) v CNI Continuation Strata 20.0-40.0 mL/Min v SRL Conversion Strata >40.0 mL/Min v CNI Continuation Strata >40.0 mL/Min
    Number of subjects included in analysis
    830
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.559 [4]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - P-value for testing the equality of rates between treatments across strata at 104 weeks.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 212 weeks
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events.An event may be categorized as serious in 1 subject and as non-serious in another, or 1 subject may have experienced both serious, non-serious event during study. EU BR specific AE tables were generated separately as per EU format using latest coding.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    SRL Conversion in Stable Renal Transplant Recipients
    Reporting group description
    Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.

    Reporting group title
    CNI Continuation in Stable Renal Transplant Recipients
    Reporting group description
    Continued calcineurin inhibitor immunosuppression therapy.

    Serious adverse events
    SRL Conversion in Stable Renal Transplant Recipients CNI Continuation in Stable Renal Transplant Recipients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    364 / 551 (66.06%)
    152 / 273 (55.68%)
         number of deaths (all causes)
    33
    11
         number of deaths resulting from adverse events
    11
    4
    Vascular disorders
    Aortic disorder
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         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
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiopathy
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accelerated hypertension
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    14 / 551 (2.54%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    7 / 16
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         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
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    9 / 551 (1.63%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 551 (0.18%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac vein occlusion
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    4 / 551 (0.73%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    4 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    2 / 551 (0.36%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Incisional hernia repair
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer surgery
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of the cervix
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoma benign
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital warts
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    9 / 551 (1.63%)
    12 / 273 (4.40%)
         occurrences causally related to treatment / all
    7 / 13
    20 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basosquamous carcinoma
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Astrocytoma malignant
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoproliferative disorder
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 551 (0.36%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    1 / 2
    7 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloma
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    4 / 551 (0.73%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    5 / 9
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin papilloma
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seminoma
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    8 / 551 (1.45%)
    13 / 273 (4.76%)
         occurrences causally related to treatment / all
    9 / 15
    20 / 48
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    3 / 551 (0.54%)
    5 / 273 (1.83%)
         occurrences causally related to treatment / all
    2 / 4
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    16 / 551 (2.90%)
    7 / 273 (2.56%)
         occurrences causally related to treatment / all
    4 / 17
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney transplant rejection
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyloidosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Unintended pregnancy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    1 / 551 (0.18%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    6 / 551 (1.09%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    9 / 551 (1.63%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    2 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic cyst
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granuloma
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperpyrexia
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    5 / 551 (0.91%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    3 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Serositis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    48 / 551 (8.71%)
    15 / 273 (5.49%)
         occurrences causally related to treatment / all
    31 / 73
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mass
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    6 / 551 (1.09%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    7 / 551 (1.27%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    4 / 551 (0.73%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Menorrhagia
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian mass
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (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 complication
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplant surgery
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic allograft nephropathy
         subjects affected / exposed
    13 / 551 (2.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    3 / 16
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site haemorrhage
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         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
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    18 / 551 (3.27%)
    8 / 273 (2.93%)
         occurrences causally related to treatment / all
    9 / 29
    2 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft complication
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft loss
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site complication
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis chemical
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    4 / 551 (0.73%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medication error
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    21 / 551 (3.81%)
    20 / 273 (7.33%)
         occurrences causally related to treatment / all
    6 / 27
    4 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin injury
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (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
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         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 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound secretion
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood parathyroid hormone increased
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood triglycerides increased
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy site unspecified abnormal
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urea increased
         subjects affected / exposed
    4 / 551 (0.73%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbohydrate antigen 125 increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug level increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium test positive
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulation time prolonged
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus test positive
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon dioxide decreased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric occult blood positive
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematology test abnormal
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases abnormal
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcus test
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    38 / 551 (6.90%)
    15 / 273 (5.49%)
         occurrences causally related to treatment / all
    16 / 53
    5 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 551 (0.54%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyanosis
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    5 / 551 (0.91%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis constrictive
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 551 (0.18%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    4 / 551 (0.73%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Cardiac failure
         subjects affected / exposed
    6 / 551 (1.09%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    7 / 551 (1.27%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    2 / 13
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    6 / 551 (1.09%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    8 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal congestion
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    5 / 551 (0.91%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    5 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar haemorrhage
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    17 / 551 (3.09%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    5 / 24
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Epistaxis
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Lung disorder
         subjects affected / exposed
    8 / 551 (1.45%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    7 / 551 (1.27%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    6 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    27 / 551 (4.90%)
    5 / 273 (1.83%)
         occurrences causally related to treatment / all
    15 / 34
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudolymphoma
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microangiopathic haemolytic anaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Anosmia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arachnoid cyst
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    3 / 551 (0.54%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain mass
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IVth nerve paralysis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningism
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uraemic encephalopathy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord paralysis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    20 / 551 (3.63%)
    5 / 273 (1.83%)
         occurrences causally related to treatment / all
    8 / 25
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphthous stomatitis
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    6 / 551 (1.09%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    36 / 551 (6.53%)
    6 / 273 (2.20%)
         occurrences causally related to treatment / all
    21 / 45
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal incontinence
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    4 / 551 (0.73%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia haemorrhagic
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 551 (0.18%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    9 / 551 (1.63%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    1 / 10
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         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 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic necrosis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 551 (0.54%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    11 / 551 (2.00%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    2 / 13
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis ulcerative
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    4 / 551 (0.73%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal rupture
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    17 / 551 (3.09%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    1 / 23
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    7 / 551 (1.27%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    1 / 10
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    5 / 551 (0.91%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    2 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    5 / 551 (0.91%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    6 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 551 (0.00%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis membranous
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis rapidly progressive
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IgA nephropathy
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Micturition urgency
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    9 / 551 (1.63%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    12 / 16
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    7 / 551 (1.27%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    4 / 7
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst haemorrhage
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    14 / 551 (2.54%)
    7 / 273 (2.56%)
         occurrences causally related to treatment / all
    6 / 20
    3 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    4 / 551 (0.73%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal disorder
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular acidosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatosplenomegaly
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         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 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis chronic active
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic pain
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis exfoliative
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatosis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exfoliative rash
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granuloma skin
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    4 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin disorder
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin exfoliation
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    1 / 551 (0.18%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    7 / 551 (1.27%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    5 / 10
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    5 / 551 (0.91%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    4 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fasciitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    7 / 551 (1.27%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    3 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism tertiary
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Calciphylaxis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyslipidaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    5 / 551 (0.91%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    15 / 551 (2.72%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    6 / 19
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    4 / 551 (0.73%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatitis B
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    6 / 551 (1.09%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    4 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 551 (0.36%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    8 / 551 (1.45%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    5 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 551 (0.36%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal sepsis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    5 / 551 (0.91%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    2 / 551 (0.36%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    27 / 551 (4.90%)
    6 / 273 (2.20%)
         occurrences causally related to treatment / all
    9 / 32
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Legionella infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    6 / 551 (1.09%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    3 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    7 / 551 (1.27%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    6 / 7
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes oesophagitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph gland infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    3 / 551 (0.54%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis bacterial
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    64 / 551 (11.62%)
    12 / 273 (4.40%)
         occurrences causally related to treatment / all
    35 / 75
    6 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 551 (0.18%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis infective
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mycosis
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    11 / 551 (2.00%)
    6 / 273 (2.20%)
         occurrences causally related to treatment / all
    5 / 13
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    11 / 551 (2.00%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    9 / 13
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyuria
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 551 (0.18%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    7 / 551 (1.27%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    8 / 10
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    3 / 551 (0.54%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic abscess
         subjects affected / exposed
    0 / 551 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinea pedis
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 551 (0.36%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculous pleurisy
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 551 (0.54%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 551 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 551 (0.18%)
    0 / 273 (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 / 551 (0.18%)
    0 / 273 (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 / 551 (0.18%)
    0 / 273 (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
    6 / 551 (1.09%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    3 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    4 / 551 (0.73%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    42 / 551 (7.62%)
    14 / 273 (5.13%)
         occurrences causally related to treatment / all
    17 / 54
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    6 / 551 (1.09%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    6 / 7
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    4 / 551 (0.73%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 1
         deaths causally related to treatment / all
    3 / 3
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    8 / 551 (1.45%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    5 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cellulitis
         subjects affected / exposed
    14 / 551 (2.54%)
    4 / 273 (1.47%)
         occurrences causally related to treatment / all
    9 / 25
    1 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    17 / 551 (3.09%)
    6 / 273 (2.20%)
         occurrences causally related to treatment / all
    14 / 28
    4 / 8
         deaths causally related to treatment / all
    2 / 3
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    SRL Conversion in Stable Renal Transplant Recipients CNI Continuation in Stable Renal Transplant Recipients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    542 / 551 (98.37%)
    258 / 273 (94.51%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    120 / 551 (21.78%)
    67 / 273 (24.54%)
         occurrences all number
    215
    125
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    36 / 551 (6.53%)
    20 / 273 (7.33%)
         occurrences all number
    43
    34
    Asthenia
         subjects affected / exposed
    39 / 551 (7.08%)
    13 / 273 (4.76%)
         occurrences all number
    55
    16
    Oedema peripheral
         subjects affected / exposed
    196 / 551 (35.57%)
    52 / 273 (19.05%)
         occurrences all number
    551
    111
    Fatigue
         subjects affected / exposed
    51 / 551 (9.26%)
    21 / 273 (7.69%)
         occurrences all number
    80
    35
    Oedema
         subjects affected / exposed
    67 / 551 (12.16%)
    23 / 273 (8.42%)
         occurrences all number
    119
    35
    Pyrexia
         subjects affected / exposed
    120 / 551 (21.78%)
    26 / 273 (9.52%)
         occurrences all number
    173
    40
    Psychiatric disorders
    Depression
         subjects affected / exposed
    34 / 551 (6.17%)
    14 / 273 (5.13%)
         occurrences all number
    66
    25
    Insomnia
         subjects affected / exposed
    42 / 551 (7.62%)
    17 / 273 (6.23%)
         occurrences all number
    81
    27
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    15 / 551 (2.72%)
    1 / 273 (0.37%)
         occurrences all number
    24
    1
    Erectile dysfunction
         subjects affected / exposed
    25 / 551 (4.54%)
    8 / 273 (2.93%)
         occurrences all number
    52
    15
    Menorrhagia
         subjects affected / exposed
    11 / 551 (2.00%)
    2 / 273 (0.73%)
         occurrences all number
    19
    2
    Ovarian cyst
         subjects affected / exposed
    13 / 551 (2.36%)
    2 / 273 (0.73%)
         occurrences all number
    33
    4
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    61 / 551 (11.07%)
    6 / 273 (2.20%)
         occurrences all number
    152
    14
    Aspartate aminotransferase increased
         subjects affected / exposed
    44 / 551 (7.99%)
    2 / 273 (0.73%)
         occurrences all number
    81
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    50 / 551 (9.07%)
    4 / 273 (1.47%)
         occurrences all number
    83
    7
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    72 / 551 (13.07%)
    6 / 273 (2.20%)
         occurrences all number
    129
    9
    Blood triglycerides increased
         subjects affected / exposed
    68 / 551 (12.34%)
    8 / 273 (2.93%)
         occurrences all number
    161
    15
    Low density lipoprotein increased
         subjects affected / exposed
    37 / 551 (6.72%)
    8 / 273 (2.93%)
         occurrences all number
    73
    19
    Weight decreased
         subjects affected / exposed
    32 / 551 (5.81%)
    11 / 273 (4.03%)
         occurrences all number
    41
    19
    Blood creatinine increased
         subjects affected / exposed
    109 / 551 (19.78%)
    48 / 273 (17.58%)
         occurrences all number
    239
    96
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    213 / 551 (38.66%)
    68 / 273 (24.91%)
         occurrences all number
    582
    147
    Leukopenia
         subjects affected / exposed
    70 / 551 (12.70%)
    17 / 273 (6.23%)
         occurrences all number
    134
    21
    Thrombocytopenia
         subjects affected / exposed
    71 / 551 (12.89%)
    12 / 273 (4.40%)
         occurrences all number
    124
    22
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    116 / 551 (21.05%)
    42 / 273 (15.38%)
         occurrences all number
    170
    66
    Dyspnoea
         subjects affected / exposed
    51 / 551 (9.26%)
    21 / 273 (7.69%)
         occurrences all number
    79
    36
    Epistaxis
         subjects affected / exposed
    53 / 551 (9.62%)
    6 / 273 (2.20%)
         occurrences all number
    82
    7
    Oropharyngeal pain
         subjects affected / exposed
    42 / 551 (7.62%)
    11 / 273 (4.03%)
         occurrences all number
    45
    13
    Nervous system disorders
    Headache
         subjects affected / exposed
    117 / 551 (21.23%)
    45 / 273 (16.48%)
         occurrences all number
    253
    70
    Dizziness
         subjects affected / exposed
    38 / 551 (6.90%)
    16 / 273 (5.86%)
         occurrences all number
    49
    26
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    32 / 551 (5.81%)
    21 / 273 (7.69%)
         occurrences all number
    46
    27
    Diarrhoea
         subjects affected / exposed
    234 / 551 (42.47%)
    83 / 273 (30.40%)
         occurrences all number
    530
    140
    Gastritis
         subjects affected / exposed
    20 / 551 (3.63%)
    17 / 273 (6.23%)
         occurrences all number
    30
    23
    Abdominal pain
         subjects affected / exposed
    54 / 551 (9.80%)
    28 / 273 (10.26%)
         occurrences all number
    67
    37
    Abdominal pain upper
         subjects affected / exposed
    27 / 551 (4.90%)
    16 / 273 (5.86%)
         occurrences all number
    36
    23
    Aphthous stomatitis
         subjects affected / exposed
    70 / 551 (12.70%)
    6 / 273 (2.20%)
         occurrences all number
    154
    12
    Constipation
         subjects affected / exposed
    38 / 551 (6.90%)
    17 / 273 (6.23%)
         occurrences all number
    52
    24
    Mouth ulceration
         subjects affected / exposed
    39 / 551 (7.08%)
    1 / 273 (0.37%)
         occurrences all number
    66
    1
    Nausea
         subjects affected / exposed
    72 / 551 (13.07%)
    27 / 273 (9.89%)
         occurrences all number
    101
    44
    Stomatitis
         subjects affected / exposed
    69 / 551 (12.52%)
    7 / 273 (2.56%)
         occurrences all number
    87
    8
    Vomiting
         subjects affected / exposed
    73 / 551 (13.25%)
    37 / 273 (13.55%)
         occurrences all number
    106
    50
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    30 / 551 (5.44%)
    23 / 273 (8.42%)
         occurrences all number
    60
    54
    Dysuria
         subjects affected / exposed
    30 / 551 (5.44%)
    12 / 273 (4.40%)
         occurrences all number
    44
    16
    Haematuria
         subjects affected / exposed
    35 / 551 (6.35%)
    11 / 273 (4.03%)
         occurrences all number
    59
    15
    Proteinuria
         subjects affected / exposed
    159 / 551 (28.86%)
    43 / 273 (15.75%)
         occurrences all number
    365
    92
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    29 / 551 (5.26%)
    4 / 273 (1.47%)
         occurrences all number
    37
    6
    Rash
         subjects affected / exposed
    62 / 551 (11.25%)
    12 / 273 (4.40%)
         occurrences all number
    103
    17
    Skin lesion
         subjects affected / exposed
    23 / 551 (4.17%)
    17 / 273 (6.23%)
         occurrences all number
    34
    62
    Acne
         subjects affected / exposed
    95 / 551 (17.24%)
    10 / 273 (3.66%)
         occurrences all number
    214
    18
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    91 / 551 (16.52%)
    54 / 273 (19.78%)
         occurrences all number
    180
    113
    Back pain
         subjects affected / exposed
    51 / 551 (9.26%)
    37 / 273 (13.55%)
         occurrences all number
    73
    71
    Muscle spasms
         subjects affected / exposed
    21 / 551 (3.81%)
    18 / 273 (6.59%)
         occurrences all number
    25
    24
    Myalgia
         subjects affected / exposed
    38 / 551 (6.90%)
    12 / 273 (4.40%)
         occurrences all number
    43
    16
    Pain in extremity
         subjects affected / exposed
    64 / 551 (11.62%)
    32 / 273 (11.72%)
         occurrences all number
    101
    50