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    Clinical Trial Results:
    An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor

    Summary
    EudraCT number
    		 2010-019631-35
    Trial protocol
    		 GB   ES   IT   SE  
    Global end of trial date
    24 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jun 2018
    First version publication date
    17 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C10-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01567085
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals, Inc.
    Sponsor organisation address
    100 College Street, New Haven, United States, 06510
    Public contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 06, clinicaltrials.eu@alexion.com
    Scientific contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 06, clinicaltrials.eu@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
    24 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2012
    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
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Australia: 18
    Worldwide total number of subjects
    80
    EEA total number of subjects
    62
    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)
    68
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eighty participants were enrolled in this study who had been transplanted and had received eculizumab to prevent acute AMR after kidney transplantation.

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

    Arms
    Arm title
    		 Eculizumab
    Arm description
    		 All eculizumab was administered intravenously (IV) over 25 to 45 minutes. Eculizumab 1200 milligrams (mg) was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eculizumab
    Investigational medicinal product code
    Other name
    Soliris
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eculizumab 1200 mg was administered IV over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.

    Number of subjects in period 1
    		Eculizumab
    Started
    80
    Received at Least 1 Dose of Study Drug
    80
    Completed
    60
    Not completed
    20
         Terminal chronic kidney dysfunction
    1
         Graft loss
    2
         Adverse event, non-fatal
    6
         Death
    6
         Returned to chronic dialysis
    1
         Lost to follow-up
    3
         Renal transplantectomy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eculizumab
    Reporting group description
    		 All eculizumab was administered intravenously (IV) over 25 to 45 minutes. Eculizumab 1200 milligrams (mg) was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.

    Reporting group values
    		 Eculizumab Total
    Number of subjects
    		 80 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 68 68
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.7 ± 11.26 -
    Gender categorical
    Units: Subjects
        Female
    		 48 48
        Male
    		 32 32
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 5 5
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 7 7
        White
    		 59 59
        Unknown or Not Reported
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    Eculizumab
    Reporting group description
    		 All eculizumab was administered intravenously (IV) over 25 to 45 minutes. Eculizumab 1200 milligrams (mg) was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.

    Subject analysis set title
    Full Analysis Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were enrolled, received a deceased donor kidney transplant, and received at least 1 dose of eculizumab.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Enrolled participants who received at least 1 dose of eculizumab.

    Primary: Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation

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    End point title
    		 Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation [1]
    End point description
    Results are reported for post-transplantation treatment failure and composite endpoints, defined as the occurrence of biopsy-proven acute AMR, graft loss, death, or loss to follow-up (including discontinuation) in the first 9 weeks post transplantation. The diagnosis of acute AMR (occurring within the first 9 weeks post transplantation) was based on kidney allograft dysfunction and a biopsy performed due to suspected rejection, proteinuria, increased serum creatinine, or acute tubular necrosis. Treatment failure was the occurrence of at least 1 of the composite endpoint components by Week 9 post transplantation. A participant experiencing multiple events was only counted once for the composite endpoint. Exact binomial test was performed to analyse treatment failure rate in first 9 weeks post transplantation, using a p-value of <0.001, where the null hypothesis was that the true failure rate = 40% (exact 95% confidence interval [3.6, 17.2]).
    End point type
    Primary
    End point timeframe
    Baseline, Week 9
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to the limitations of the EudraCT database, the process used for the calculation of the p-value and the p-value were reported in the endpoint description.
    End point values
    		 Eculizumab
    Number of subjects analysed
    80 [2]
    Units: Participants
        Treatment Failure - Yes
    7
        Treatment Failure - No
    73
        Biopsy proven acute AMR
    3
        Graft Loss
    4
        Death
    1
        Lost to Follow-Up, including discontinuation
    1
    Notes
    [2] - Full Analysis Population
    No statistical analyses for this end point

    Other pre-specified: Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12

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    End point title
    		 Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12
    End point description
    Specific analyses of other AEs of interest that occurred at Month 12 included cumulative incidence of clinically significant infection (CSI); post-transplant lymphoproliferative disease (PTLD); malignancies; biopsy-proven acute cellular rejection (ACR) of any grade meeting Banff 2007 criteria; allograft loss for reasons other than AMR. CSIs were defined as infections (confirmed by culture, biopsy, genomic, or serologic findings) that required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator. CSI subcategories of interest included cytomegalovirus (CMV) disease; BK virus disease; encapsulated bacterial infection; fungal infections; aspergillus infections. Results are reported as CIF, where a larger CIF indicates a higher incidence of an AE, and were calculated using Statistical Analysis System software and macro CIF. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Month 12
    End point values
    		 Eculizumab
    Number of subjects analysed
    80 [3]
    Units: Units On A Scale
    number (confidence interval 95%)
        Confirmed CSI
    0.7989 (0.69 to 0.87)
        CMV Infection
    0.2994 (0.20 to 0.40)
        BK Virus Infection
    0.1536 (0.08 to 0.24)
        Encapsulated Bacterial Infection
    0.1642 (0.09 to 0.25)
        Fungal Infection
    0.1287 (0.07 to 0.21)
        Aspergillus Infection
    0 (0 to 0)
        PTLD
    0.0264 (0.00 to 0.08)
        Malignancies
    0.0264 (0.00 to 0.08)
        Biopsy-proven ACR
    0.0375 (0.01 to 0.10)
        Allograft Loss
    0.1132 (0.06 to 0.19)
    Notes
    [3] - Safety Population
    No statistical analyses for this end point

    Other pre-specified: Participants That Developed Severe ACR (Other AE Of Interest) At Month 12

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    End point title
    		 Participants That Developed Severe ACR (Other AE Of Interest) At Month 12
    End point description
    This outcome measure focuses on the other AE of interest, severe ACR that occurred at Month 12. It pertains specifically to the number of participants who developed severe ACR that did not respond to thymoglobulin or other lymphocyte-depleting agents. A summary of serious and all other non-serious AEs, regardless of causality, is located in the reported Adverse events module.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Month 12
    End point values
    		 Eculizumab
    Number of subjects analysed
    80 [4]
    Units: Participants
    3
    Notes
    [4] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Eculizumab
    Reporting group description
    		 All eculizumab was administered intravenously (IV) over 25 to 45 minutes. Eculizumab 1200 milligrams (mg) was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.

    Serious adverse events
    		 Eculizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    70 / 80 (87.50%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Medullary thyroid cancer
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neuroendocrine tumour
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Refractory anaemia with an excess of blasts
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Arterial disorder
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lymphocele
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Plastic surgery
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pre-eclampsia
         subjects affected / exposed [1]
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Premature delivery
         subjects affected / exposed [2]
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter site pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Kidney transplant rejection
         subjects affected / exposed
    25 / 80 (31.25%)
         occurrences causally related to treatment / all
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Vaginal dysplasia
         subjects affected / exposed [3]
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Antibody test positive
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Delayed graft function
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary anastomotic leak
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Colitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Gingivitis ulcerative
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Palatal disorder
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Umbilical hernia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    12 / 80 (15.00%)
         occurrences causally related to treatment / all
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    Anuria
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal cyst
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal cyst haemorrhage
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal haematoma
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal impairment
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal vascular thrombosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal vein thrombosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinoma
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    BK virus infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Candiduria
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gingival abscess
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic cyst infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis C
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Incision site infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infected fistula
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Pneumonia cryptococcal
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Systemic mycosis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tooth infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Calciphylaxis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This adverse event is possible in female participants only. The total number of female participants in the study is 48.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This adverse event is possible in female participants only. The total number of female participants in the study is 48.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This adverse event is possible in female participants only. The total number of female participants in the study is 48.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Eculizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 80 (97.50%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Haematoma
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Hypertension
         subjects affected / exposed
    31 / 80 (38.75%)
         occurrences all number
    36
    Hypotension
         subjects affected / exposed
    13 / 80 (16.25%)
         occurrences all number
    15
    Lymphocele
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Orthostatic hypotension
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    8
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    13 / 80 (16.25%)
         occurrences all number
    17
    Chest pain
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    9
    Influenza like illness
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    9
    Oedema
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Oedema peripheral
         subjects affected / exposed
    31 / 80 (38.75%)
         occurrences all number
    48
    Pain
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    20 / 80 (25.00%)
         occurrences all number
    28
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Kidney transplant rejection
         subjects affected / exposed
    22 / 80 (27.50%)
         occurrences all number
    32
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    18 / 80 (22.50%)
         occurrences all number
    23
    Dyspnoea
         subjects affected / exposed
    19 / 80 (23.75%)
         occurrences all number
    23
    Dyspnoea exertional
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Pleural effusion
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Productive cough
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Rales
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Insomnia
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    13
    Anxiety
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    10
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    15 / 80 (18.75%)
         occurrences all number
    20
    Cardiac murmur
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Liver function test abnormal
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    8
    Weight decreased
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    7
    Weight increased
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    10
    Delayed graft function
         subjects affected / exposed
    12 / 80 (15.00%)
         occurrences all number
    12
    Incisional hernia
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    6
    Post procedural haematoma
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Procedural pain
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    13
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Palpitations
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Tachycardia
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Headache
         subjects affected / exposed
    22 / 80 (27.50%)
         occurrences all number
    33
    Tremor
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    51 / 80 (63.75%)
         occurrences all number
    65
    Leukopenia
         subjects affected / exposed
    30 / 80 (37.50%)
         occurrences all number
    43
    Lymphopenia
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    14
    Neutropenia
         subjects affected / exposed
    18 / 80 (22.50%)
         occurrences all number
    22
    Pancytopenia
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    9
    Thrombocytopenia
         subjects affected / exposed
    12 / 80 (15.00%)
         occurrences all number
    19
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    14 / 80 (17.50%)
         occurrences all number
    19
    Abdominal pain upper
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    15 / 80 (18.75%)
         occurrences all number
    17
    Diarrhoea
         subjects affected / exposed
    37 / 80 (46.25%)
         occurrences all number
    70
    Dyspepsia
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Gastritis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    12 / 80 (15.00%)
         occurrences all number
    14
    Haemorrhoids
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Mouth ulceration
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    11
    Nausea
         subjects affected / exposed
    25 / 80 (31.25%)
         occurrences all number
    36
    Vomiting
         subjects affected / exposed
    18 / 80 (22.50%)
         occurrences all number
    22
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    10
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    6
    Pruritus
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    9
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    10
    Dysuria
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    11
    Haematuria
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    14
    Oliguria
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Polyuria
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Proteinuria
         subjects affected / exposed
    16 / 80 (20.00%)
         occurrences all number
    18
    Renal artery stenosis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Renal impairment
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    16
    Renal tubular necrosis
         subjects affected / exposed
    13 / 80 (16.25%)
         occurrences all number
    13
    Urinary incontinence
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    8
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 80 (15.00%)
         occurrences all number
    18
    Muscle spasms
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Musculoskeletal pain
         subjects affected / exposed
    19 / 80 (23.75%)
         occurrences all number
    34
    Infections and infestations
    BK virus infection
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    18
    Bronchitis
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    10
    Clostridium difficile infection
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Conjunctivitis
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Cytomegalovirus infection
         subjects affected / exposed
    21 / 80 (26.25%)
         occurrences all number
    33
    Ear infection
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Enterococcal infection
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Escherichia infection
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    8
    Escherichia urinary tract infection
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    18
    Gastroenteritis
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    10
    Gastroenteritis norovirus
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Herpes simplex
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    12
    Oral candidiasis
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Pneumonia
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    13
    Urinary tract infection
         subjects affected / exposed
    32 / 80 (40.00%)
         occurrences all number
    65
    Urinary tract infection bacterial
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    11
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    21 / 80 (26.25%)
         occurrences all number
    27
    Cell death
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    5
    Decreased appetite
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    8
    Dehydration
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Diabetes mellitus
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    13
    Diabetes mellitus inadequate control
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    6
    Fluid overload
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    10
    Hypercalcaemia
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    10
    Hypercholesterolaemia
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    7
    Hyperglycaemia
         subjects affected / exposed
    14 / 80 (17.50%)
         occurrences all number
    15
    Hyperkalaemia
         subjects affected / exposed
    23 / 80 (28.75%)
         occurrences all number
    27
    Hyperlipidaemia
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Hyperphosphataemia
         subjects affected / exposed
    10 / 80 (12.50%)
         occurrences all number
    10
    Hypocalcaemia
         subjects affected / exposed
    14 / 80 (17.50%)
         occurrences all number
    18
    Hypoglycaemia
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    8
    Hypokalaemia
         subjects affected / exposed
    18 / 80 (22.50%)
         occurrences all number
    24
    Hypomagnesaemia
         subjects affected / exposed
    16 / 80 (20.00%)
         occurrences all number
    20
    Hyponatraemia
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    10
    Hypophosphataemia
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    11
    Vitamin D deficiency
         subjects affected / exposed
    8 / 80 (10.00%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2013
    The main purpose of this amendment was to reopen the recruitment of participants following the investigator's request.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None
    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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