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    Clinical Trial Results:
    A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.

    Summary
    EudraCT number
    		 2013-004650-25
    Trial protocol
    		 DE   IT   ES   CZ   FR  
    Global end of trial date
    22 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Dec 2017
    First version publication date
    14 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ECU-DGF-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02145182
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals Inc.
    Sponsor organisation address
    100 College St., New Haven CT, United States, 06510
    Public contact
    Study Director, Alexion Pharmaceuticals Inc., clinicaltrials@alexion.com
    Scientific contact
    Study Director, Alexion Pharmaceuticals Inc., clinicaltrials@alexion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 As expected, concomitant medications were used by all 288 participants during the study, because immunosuppressants and prophylactic medications were required to maintain allograft function and prevent infection in participants undergoing kidney transplant.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Aug 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Brazil: 5
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Czech Republic: 25
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Spain: 55
    Country: Number of subjects enrolled
    United States: 134
    Worldwide total number of subjects
    288
    EEA total number of subjects
    134
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    182
    From 65 to 84 years
    106
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Fifty-nine centers in Australia, Brazil, Canada, Czech Republic, France, Germany, Italy, Spain, and the United States of America participated in this study. The study recruited participants who had been receiving dialysis for a median of approximately 50 months before undergoing transplantation and received a kidney from a deceased donor.

    Pre-assignment
    Screening details
    		 Written consent was provided prior to study-required assessments (N=333). Participants who passed screening (N=314) were vaccinated against Neisseria meningitidis. A total of 314 were randomized; of these, 286 underwent transplantation and received eculizumab or placebo. Two participants received placebo but withdrew prior to transplantation.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Matching placebo intravenous (IV) solution will be administered to participants in the Placebo arm.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eculizumab
    Arm description
    		 Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 hours (h) of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 minutes (min). The first dose was 1200 milligrams (mg) in 240 milliliters (mL) (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
    Arm type
    		 Experimental

    Investigational medicinal product name
    eculizumab
    Investigational medicinal product code
    Other name
    Soliris
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Two doses in total, each administered by IV infusion over 25 to 45 min. Dose 1: 1200 mg in 240 mL (5 mg/mL) just prior to reperfusion of the allograft. Dose 2: 900 mg in 180 mL (5 mg/mL) within 18 to 24 h of completion of administration of the first dose.

    Arm title
    		 Placebo
    Arm description
    		 Participants received 2 doses of placebo (0.9% sodium chloride [NaCl]): the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Two doses in total, each administered by IV infusion over 25 to 45 min. Dose 1: 240 mL of 0.9% NaCl just prior to reperfusion of the allograft. Dose 2: 180 mL of 0.9% NaCl within 18 to 24 h of completion of administration of the first dose.

    Number of subjects in period 1
    		Eculizumab Placebo
    Started
    142
    146
    Received  at Least 1 Dose of Study Drug
    142
    146
    Completed
    124
    130
    Not completed
    18
    16
         Adverse event, serious fatal
    7
    7
         Consent withdrawn by subject
    5
    4
         Adverse event, non-fatal
    4
    1
         Pre-transplant withdrawal
    -
    2
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eculizumab
    Reporting group description
    		 Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 hours (h) of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 minutes (min). The first dose was 1200 milligrams (mg) in 240 milliliters (mL) (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 2 doses of placebo (0.9% sodium chloride [NaCl]): the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.

    Reporting group values
    		 Eculizumab Placebo Total
    Number of subjects
    		 142 146 288
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.5 ( 12.29 ) 57.1 ( 13.03 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 45 92
        Male
    		 95 101 196
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 23 23 46
        Not Hispanic or Latino
    		 108 113 221
        Unknown or Not Reported
    		 11 10 21
    Race/Ethnicity
    Units: Subjects
        American Indian or Alaskan Native
    		 1 2 3
        Asian
    		 0 4 4
        Black or African American
    		 38 37 75
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        White
    		 88 92 180
        Other
    		 9 7 16
        Multiple
    		 1 1 2
        Unknown
    		 4 3 7

    End points

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    End points reporting groups
    Reporting group title
    Eculizumab
    Reporting group description
    		 Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 hours (h) of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 minutes (min). The first dose was 1200 milligrams (mg) in 240 milliliters (mL) (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 2 doses of placebo (0.9% sodium chloride [NaCl]): the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab).

    Primary: Percentage Of Participants With DGF In The First Seven Days Post-transplant

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    End point title
    		 Percentage Of Participants With DGF In The First Seven Days Post-transplant
    End point description
    Results are reported for the DGF composite endpoint, defined as the occurrence of DGF (dialysis for any reason in the first 7 days post transplantation), graft loss, death, or loss to follow-up (including discontinuation) in the first 7 days post transplantation and for each item of the composite endpoint.
    End point type
    Primary
    End point timeframe
    First 7 days post transplantation
    End point values
    		 Eculizumab Placebo
    Number of subjects analysed
    142 [1]
    144 [2]
    Units: Percentage of participants
    number (not applicable)
        DGF Composite
    35.9
    41.7
        DGF
    33.8
    39.6
        Death
    0.0
    1.4
        Graft Loss
    0.7
    3.5
        Lost to Follow-up (including discontinuation)
    3.5
    1.4
    Notes
    [1] - Full Analysis Set
    [2] - Full Analysis Set
    Statistical analysis title
    		 Analysis of DGF composite
    Comparison groups
    Placebo v Eculizumab
    Number of subjects included in analysis
    286
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3983 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.33
    Notes
    [3] - Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type and donor type, and Irish score.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Eculizumab
    Reporting group description
    		 Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 2 doses of placebo (0.9% NaCl): the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.

    Serious adverse events
    		 Eculizumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    92 / 142 (64.79%)
    102 / 146 (69.86%)
         number of deaths (all causes)
    8
    7
         number of deaths resulting from adverse events
    8
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arteriovenous fistula
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
    1 / 142 (0.70%)
    7 / 146 (4.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         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 / 142 (0.70%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphorrhoea
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    4 / 142 (2.82%)
    4 / 146 (2.74%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney transplant rejection
         subjects affected / exposed
    4 / 142 (2.82%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 142 (0.00%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal haematoma
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haematoma
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 142 (1.41%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 142 (2.11%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Biopsy kidney abnormal
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine increased
         subjects affected / exposed
    3 / 142 (2.11%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Donor specific antibody present
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine output decreased
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    4 / 142 (2.82%)
    4 / 146 (2.74%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed graft function
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft haemorrhage
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft loss
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haematoma
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephric collection
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirenal haematoma
         subjects affected / exposed
    1 / 142 (0.70%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural urine leak
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant dysfunction
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary anastomotic leak
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound decomposition
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 142 (0.00%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 142 (0.70%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 142 (0.00%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 142 (0.70%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuromyopathy
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 142 (3.52%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
    3 / 142 (2.11%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal ulcer
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal perforation
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal hernia
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 142 (1.41%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder perforation
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panniculitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 142 (2.11%)
    6 / 146 (4.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder outlet obstruction
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesangioproliferative glomerulonephritis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive nephropathy
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery dissection
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 142 (0.00%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst haemorrhage
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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 / 142 (0.00%)
    1 / 146 (0.68%)
         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
    2 / 142 (1.41%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal vein thrombosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (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
    2 / 142 (1.41%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral haemorrhage
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary fistula
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract disorder
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism secondary
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis moraxella
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
    3 / 142 (2.11%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    3 / 142 (2.11%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 142 (0.00%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    3 / 142 (2.11%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    3 / 142 (2.11%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intervertebral discitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nocardiosis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 142 (4.93%)
    8 / 146 (5.48%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 142 (0.70%)
    4 / 146 (2.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonella sepsis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 142 (1.41%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Septic shock
         subjects affected / exposed
    4 / 142 (2.82%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    7 / 142 (4.93%)
    4 / 146 (2.74%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    3 / 142 (2.11%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    6 / 142 (4.23%)
    3 / 146 (2.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound abscess
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (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
    Acidosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calciphylaxis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 142 (0.70%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    9 / 142 (6.34%)
    5 / 146 (3.42%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Eculizumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 142 (97.89%)
    142 / 146 (97.26%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    34 / 142 (23.94%)
    39 / 146 (26.71%)
         occurrences all number
    37
    43
    Hypotension
         subjects affected / exposed
    29 / 142 (20.42%)
    33 / 146 (22.60%)
         occurrences all number
    31
    37
    Lymphocele
         subjects affected / exposed
    9 / 142 (6.34%)
    4 / 146 (2.74%)
         occurrences all number
    10
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 142 (8.45%)
    20 / 146 (13.70%)
         occurrences all number
    12
    23
    Chest pain
         subjects affected / exposed
    6 / 142 (4.23%)
    11 / 146 (7.53%)
         occurrences all number
    6
    12
    Oedema
         subjects affected / exposed
    7 / 142 (4.93%)
    8 / 146 (5.48%)
         occurrences all number
    9
    10
    Oedema peripheral
         subjects affected / exposed
    41 / 142 (28.87%)
    57 / 146 (39.04%)
         occurrences all number
    55
    77
    Pyrexia
         subjects affected / exposed
    26 / 142 (18.31%)
    20 / 146 (13.70%)
         occurrences all number
    31
    20
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    14 / 142 (9.86%)
    7 / 146 (4.79%)
         occurrences all number
    16
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 142 (4.23%)
    9 / 146 (6.16%)
         occurrences all number
    6
    10
    Dyspnoea
         subjects affected / exposed
    10 / 142 (7.04%)
    10 / 146 (6.85%)
         occurrences all number
    11
    10
    Dyspnoea exertional
         subjects affected / exposed
    1 / 142 (0.70%)
    9 / 146 (6.16%)
         occurrences all number
    1
    9
    Oropharyngeal pain
         subjects affected / exposed
    5 / 142 (3.52%)
    10 / 146 (6.85%)
         occurrences all number
    5
    10
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    10 / 142 (7.04%)
    10 / 146 (6.85%)
         occurrences all number
    11
    11
    Insomnia
         subjects affected / exposed
    16 / 142 (11.27%)
    16 / 146 (10.96%)
         occurrences all number
    18
    16
    Investigations
    Blood creatine increased
         subjects affected / exposed
    14 / 142 (9.86%)
    21 / 146 (14.38%)
         occurrences all number
    14
    21
    Urine output decreased
         subjects affected / exposed
    5 / 142 (3.52%)
    11 / 146 (7.53%)
         occurrences all number
    6
    11
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    30 / 142 (21.13%)
    21 / 146 (14.38%)
         occurrences all number
    33
    22
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    9 / 142 (6.34%)
    10 / 146 (6.85%)
         occurrences all number
    14
    11
    Tachycardia
         subjects affected / exposed
    17 / 142 (11.97%)
    12 / 146 (8.22%)
         occurrences all number
    20
    13
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 142 (3.52%)
    10 / 146 (6.85%)
         occurrences all number
    7
    10
    Headache
         subjects affected / exposed
    13 / 142 (9.15%)
    10 / 146 (6.85%)
         occurrences all number
    13
    11
    Tremor
         subjects affected / exposed
    21 / 142 (14.79%)
    28 / 146 (19.18%)
         occurrences all number
    21
    29
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    77 / 142 (54.23%)
    75 / 146 (51.37%)
         occurrences all number
    90
    82
    Leukocytosis
         subjects affected / exposed
    8 / 142 (5.63%)
    7 / 146 (4.79%)
         occurrences all number
    8
    8
    Leukopenia
         subjects affected / exposed
    37 / 142 (26.06%)
    30 / 146 (20.55%)
         occurrences all number
    45
    32
    Thrombocytopenia
         subjects affected / exposed
    24 / 142 (16.90%)
    15 / 146 (10.27%)
         occurrences all number
    24
    15
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    13 / 142 (9.15%)
    14 / 146 (9.59%)
         occurrences all number
    13
    15
    Constipation
         subjects affected / exposed
    40 / 142 (28.17%)
    40 / 146 (27.40%)
         occurrences all number
    44
    48
    Diarrhoea
         subjects affected / exposed
    37 / 142 (26.06%)
    35 / 146 (23.97%)
         occurrences all number
    42
    39
    Dyspepsia
         subjects affected / exposed
    9 / 142 (6.34%)
    8 / 146 (5.48%)
         occurrences all number
    11
    8
    Nausea
         subjects affected / exposed
    36 / 142 (25.35%)
    32 / 146 (21.92%)
         occurrences all number
    48
    36
    Vomiting
         subjects affected / exposed
    30 / 142 (21.13%)
    24 / 146 (16.44%)
         occurrences all number
    35
    27
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    11 / 142 (7.75%)
    9 / 146 (6.16%)
         occurrences all number
    11
    9
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    6 / 142 (4.23%)
    10 / 146 (6.85%)
         occurrences all number
    6
    11
    Bladder spasm
         subjects affected / exposed
    6 / 142 (4.23%)
    8 / 146 (5.48%)
         occurrences all number
    6
    8
    Dysuria
         subjects affected / exposed
    14 / 142 (9.86%)
    20 / 146 (13.70%)
         occurrences all number
    14
    20
    Haematuria
         subjects affected / exposed
    14 / 142 (9.86%)
    15 / 146 (10.27%)
         occurrences all number
    17
    16
    Proteinuria
         subjects affected / exposed
    8 / 142 (5.63%)
    6 / 146 (4.11%)
         occurrences all number
    8
    6
    Renal tubular necrosis
         subjects affected / exposed
    15 / 142 (10.56%)
    10 / 146 (6.85%)
         occurrences all number
    15
    10
    Urinary retention
         subjects affected / exposed
    8 / 142 (5.63%)
    5 / 146 (3.42%)
         occurrences all number
    8
    5
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 142 (8.45%)
    9 / 146 (6.16%)
         occurrences all number
    15
    9
    Musculoskeletal pain
         subjects affected / exposed
    10 / 142 (7.04%)
    15 / 146 (10.27%)
         occurrences all number
    10
    18
    Infections and infestations
    BK virus infection
         subjects affected / exposed
    18 / 142 (12.68%)
    18 / 146 (12.33%)
         occurrences all number
    21
    19
    Cytomegalovirus infection
         subjects affected / exposed
    17 / 142 (11.97%)
    17 / 146 (11.64%)
         occurrences all number
    18
    19
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 142 (2.82%)
    10 / 146 (6.85%)
         occurrences all number
    4
    11
    Urinary tract infection
         subjects affected / exposed
    22 / 142 (15.49%)
    33 / 146 (22.60%)
         occurrences all number
    27
    44
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    35 / 142 (24.65%)
    24 / 146 (16.44%)
         occurrences all number
    42
    24
    Decreased appetite
         subjects affected / exposed
    3 / 142 (2.11%)
    8 / 146 (5.48%)
         occurrences all number
    3
    8
    Diabetes mellitus
         subjects affected / exposed
    12 / 142 (8.45%)
    6 / 146 (4.11%)
         occurrences all number
    12
    6
    Diabetes mellitus inadequate control
         subjects affected / exposed
    10 / 142 (7.04%)
    15 / 146 (10.27%)
         occurrences all number
    10
    16
    Fluid overload
         subjects affected / exposed
    12 / 142 (8.45%)
    26 / 146 (17.81%)
         occurrences all number
    14
    28
    Hypercalcaemia
         subjects affected / exposed
    11 / 142 (7.75%)
    7 / 146 (4.79%)
         occurrences all number
    12
    7
    Hyperglycaemia
         subjects affected / exposed
    31 / 142 (21.83%)
    23 / 146 (15.75%)
         occurrences all number
    34
    23
    Hyperkalaemia
         subjects affected / exposed
    59 / 142 (41.55%)
    67 / 146 (45.89%)
         occurrences all number
    76
    92
    Hyperphosphataemia
         subjects affected / exposed
    13 / 142 (9.15%)
    16 / 146 (10.96%)
         occurrences all number
    13
    16
    Hypocalcaemia
         subjects affected / exposed
    33 / 142 (23.24%)
    23 / 146 (15.75%)
         occurrences all number
    37
    24
    Hypoglycaemia
         subjects affected / exposed
    7 / 142 (4.93%)
    10 / 146 (6.85%)
         occurrences all number
    7
    10
    Hypokalaemia
         subjects affected / exposed
    12 / 142 (8.45%)
    25 / 146 (17.12%)
         occurrences all number
    12
    25
    Hypomagnesaemia
         subjects affected / exposed
    40 / 142 (28.17%)
    28 / 146 (19.18%)
         occurrences all number
    46
    32
    Hyponatraemia
         subjects affected / exposed
    8 / 142 (5.63%)
    12 / 146 (8.22%)
         occurrences all number
    10
    13
    Hypophosphataemia
         subjects affected / exposed
    28 / 142 (19.72%)
    19 / 146 (13.01%)
         occurrences all number
    29
    20
    Vitamin D deficiency
         subjects affected / exposed
    7 / 142 (4.93%)
    8 / 146 (5.48%)
         occurrences all number
    7
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2014
    This amendment included the following changes: * The number of study centers was changed from 70 to 80 centers to more accurately reflect the number of centers for the ECU-DGF-201 study. * Listed all the diluents allowed per the protocol for the study drug preparation. * Specified that it was the investigative sites’ responsibility to administer mycophenolate mofetil according to the instructions in the approved product label as per a United States Food and Drug Administration request. * Provided information on the type of vaccination for N meningitidis (a tetravalent [quadrivalent]) conjugated vaccine and specified that sites were permitted to use the serotype B vaccine for additional coverage when available. * Provided additional guidance for monitoring of anaphylactic reactions. * Specified that if an adverse event (AE) changed in severity over the duration of the event, this AE should not have been considered a new AE and the maximum (worst) severity should have been reported. * Updated the process of Investigator reporting of unexpected, serious, drug-related events.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Because this was a negative study and did not demonstrate treatment effect, not all efficacy results are reported. Sample data were collected, but not analyzed to obtain outcome measure data. As such, a summary of these data sets is not possible.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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