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    Clinical Trial Results:
    AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYSENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)

    Summary
    EudraCT number
    		 2008-006955-28
    Trial protocol
    		 DE   NL   SE   AT   ES   GB   IT  
    Global end of trial date
    10 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jul 2016
    First version publication date
    24 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C08-003B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00844428
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 BB-IND 11075: BB-IND 11075
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals Incorporated
    Sponsor organisation address
    352 Knotter Drive, Cheshire, CT, United States, 06410
    Public contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 06, clinicaltrials.eu@alxn.com
    Scientific contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 06, clinicaltrials.eu@alxn.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
    29 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of eculizumab on TMA-Event Free status defined as the absence for at least 12 weeks of [1] decrease in platelet count of >25% from the Platelet Count Pre-PT Baseline Set-Point; [2] PT while the patient is receiving eculizumab, or [3] new dialysis
    Protection of trial subjects
    Vaccination against N. meningitidis at least 14 days prior to study drug initiation or prophylactic antibiotics protection until 2 weeks after vaccination
    Background therapy
    		 -
    Evidence for comparator
    		 Eeach patient served as his/her own control
    Actual start date of recruitment
    24 Jul 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Sweden: 1
    Worldwide total number of subjects
    20
    EEA total number of subjects
    18
    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)
    5
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Results from Study C08-003A were combined with results from another study, Study C08-003B. Study C08-003A was conducted in adults (n=15) and Study C08-003B was conducted in adolescents (n=5; EudraCT No.: 2008-006955-28). Combined results from these 2 studies are reported here.

    Pre-assignment
    Screening details
    		 Patients receiving PT for aHUS and observed to receive ≥ 1 PT every two weeks, and no more than 3 PT treatments/week for at least 8 weeks before the first dose of eculizumab. Patients who met the eligibility criteria during the Observation Period were enrolled into the Treatment Period which commenced with the first eculizumab dose.

    Pre-assignment period milestones
    Number of subjects started
    		 23 [1]
    Number of subjects completed
    		 20

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Period 1 is the observation period during which baseline is assessed.
    Period 1
    Period 1 title
    Observation Period (8 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Observation
    Arm description
    		 During the 8-week Observation Period, clinical laboratory testing, platelet counts, hemolytic markers, pro-thrombotic measures, pro-inflammatory markers, complement markers, and samples for renal function measures were collected on a weekly basis. Adverse events were also recorded on a weekly basis during the 8-week Observation Period. Additionally, all PT sessions administered to the patient during the Observation Period were recorded
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Observation
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    Treatment Period (26 Weeks)
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 eculizumab
    Arm description
    		 All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange. The intent-to-treat (ITT) population was defined as all patients who received any amount of eculizumab, and were considered evaluable for safety and efficacy analyses. For both the efficacy and safety analyses, all 20 patients who were treated with study drug were included in the ITT population.
    Arm type
    		 Experimental

    Investigational medicinal product name
    eculizumab
    Investigational medicinal product code
    eculizumab
    Other name
    SOliris
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later Maintenance dose - 1200 mg every two weeks Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The post-treatment period only applies to the patients who discontinued treatment. There are 5 patients who were off drug at end of study.
    Number of subjects in period 2
    		eculizumab
    Started
    20
    Completed
    20
    Period 3
    Period 3 title
    Extension Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 long-term eculizumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    eculizumab
    Investigational medicinal product code
    eculizumab
    Other name
    Soliris
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later Maintenance dose - 1200 mg every two weeks Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

    Number of subjects in period 3 [3]
    		long-term eculizumab
    Started
    19
    Completed
    18
    Not completed
    1
         Death
    1
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: All analyses summarize results from pooled data of 2 protocols: C08-003A and C08-003B. One adolescent patient (from study C08-003B) discontinued from the study after 26 weeks.
    Period 4
    Period 4 title
    Post-treatment period (discontinuation)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 eculizumab
    Arm description
    		 Patients who discontinued eculizumab during the study were required to have follow-up visits. These assessments were performed at 1 week, 2 weeks, 4 weeks, and 8 weeks after the last dose of eculizumab.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4 [4]
    		eculizumab
    Started
    5
    Completed
    4
    Not completed
    1
         Adverse event, serious fatal
    1
    Notes
    [4] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The worldwide number enrolled in the trial do not include screen failure.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    eculizumab
    Reporting group description
    		 All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange. The intent-to-treat (ITT) population was defined as all patients who received any amount of eculizumab, and were considered evaluable for safety and efficacy analyses. For both the efficacy and safety analyses, all 20 patients who were treated with study drug were included in the ITT population.

    Reporting group values
    		 eculizumab Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 5 5
        Adults (18-64 years)
    		 15 15
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.3 ( 14.92 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 8 8
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 2 2
        White
    		 18 18
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Platelet Category
    Units: Subjects
        < 150 x10^9/L
    		 3 3
        >= 150 x10^9/L
    		 17 17
    LDH Category
    Units: Subjects
        > ULN
    		 4 4
        ≤ ULN
    		 16 16
    eGFR category
    Units: Subjects
        < 15
    		 4 4
        15 ≤ 30
    		 6 6
        30 ≤ 45
    		 6 6
        45 ≤ 60
    		 2 2
        60 ≤ 90
    		 2 2
    CKD
    Units: Subjects
        Stage 2
    		 2 2
        Stage 3a
    		 2 2
        Stage 3b
    		 6 6
        Stage 4
    		 6 6
        Stage 5
    		 4 4
    Platelet Count
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 227.98 ( 77.658 ) -
    LDH
    Units: U/l
        arithmetic mean (standard deviation)
    		 222.6 ( 69.88 ) -
    Creatinine
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    		 286.9 ( 215.44 ) -
    eGFR
    Units: mL/min/1.73*m^2
        arithmetic mean (standard deviation)
    		 30.9 ( 19.01 ) -

    End points

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    End points reporting groups
    Reporting group title
    Observation
    Reporting group description
    		 During the 8-week Observation Period, clinical laboratory testing, platelet counts, hemolytic markers, pro-thrombotic measures, pro-inflammatory markers, complement markers, and samples for renal function measures were collected on a weekly basis. Adverse events were also recorded on a weekly basis during the 8-week Observation Period. Additionally, all PT sessions administered to the patient during the Observation Period were recorded
    Reporting group title
    eculizumab
    Reporting group description
    		 All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange. The intent-to-treat (ITT) population was defined as all patients who received any amount of eculizumab, and were considered evaluable for safety and efficacy analyses. For both the efficacy and safety analyses, all 20 patients who were treated with study drug were included in the ITT population.
    Reporting group title
    long-term eculizumab
    Reporting group description
    		 -
    Reporting group title
    eculizumab
    Reporting group description
    		 Patients who discontinued eculizumab during the study were required to have follow-up visits. These assessments were performed at 1 week, 2 weeks, 4 weeks, and 8 weeks after the last dose of eculizumab.

    Primary: Proportion of Patients With TMA Event-free Status

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    End point title
    		 Proportion of Patients With TMA Event-free Status [1]
    End point description
    TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.
    End point type
    Primary
    End point timeframe
    Through 26 weeks
    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: This study is a single arm trial and the system does not support statistical analyses for single arm trial.
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    80 (56 to 94)
    No statistical analyses for this end point

    Primary: Proportion of Patients With Hematologic Normalization

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    End point title
    		 Proportion of Patients With Hematologic Normalization [2]
    End point description
    Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.
    End point type
    Primary
    End point timeframe
    Through 26 weeks
    Notes
    [2] - 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: This study is a single arm trial and the system does not support statistical analyses for single arm trial.
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    90 (68 to 99)
    No statistical analyses for this end point

    Primary: Proportion of Patients With Complete TMA Response

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    End point title
    		 Proportion of Patients With Complete TMA Response [3]
    End point description
    The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.
    End point type
    Primary
    End point timeframe
    Through 26 weeks
    Notes
    [3] - 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: This study is a single arm trial and the system does not support statistical analyses for single arm trial.
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    25 (9 to 49)
    No statistical analyses for this end point

    Secondary: TMA Intervention Rate

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    End point title
    		 TMA Intervention Rate
    End point description
    TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.
    End point type
    Secondary
    End point timeframe
    Through 26 weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: #events/patient/day
        arithmetic mean (standard deviation)
    0 ( 0 )
    No statistical analyses for this end point

    Secondary: Platelet Count Change From Baseline to 26 Weeks

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    End point title
    		 Platelet Count Change From Baseline to 26 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to 26 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: 10^9 cells/L
        least squares mean (confidence interval 95%)
    6.75 (-15.73 to 29.23)
    No statistical analyses for this end point

    Secondary: Proportion of Patients With Platelet Count Normalization

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    End point title
    		 Proportion of Patients With Platelet Count Normalization
    End point description
    Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least 2 consecutive measurements which span a period of at least 4 weeks.
    End point type
    Secondary
    End point timeframe
    Through 26 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    90 (68 to 99)
    No statistical analyses for this end point

    Secondary: Proportion of Patients With TMA Event-free Status

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    End point title
    		 Proportion of Patients With TMA Event-free Status
    End point description
    TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.
    End point type
    Secondary
    End point timeframe
    Through End of Study, Median Exposure 156 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    95 (75 to 100)
    No statistical analyses for this end point

    Secondary: Proportion of Patients With Hematologic Normalization

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    End point title
    		 Proportion of Patients With Hematologic Normalization
    End point description
    Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.
    End point type
    Secondary
    End point timeframe
    Through End of Study, Median Exposure 156 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    90 (68 to 99)
    No statistical analyses for this end point

    Secondary: Proportion of Patients With Complete TMA Response

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    End point title
    		 Proportion of Patients With Complete TMA Response
    End point description
    The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.
    End point type
    Secondary
    End point timeframe
    Through End of Study, Median Exposure 156 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    55 (32 to 77)
    No statistical analyses for this end point

    Secondary: TMA Intervention Rate

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    End point title
    		 TMA Intervention Rate
    End point description
    TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the 15th day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.
    End point type
    Secondary
    End point timeframe
    Through End of Study, Median Exposure 156 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: #events/patient/day
        arithmetic mean (standard deviation)
    0 ( 0.02 )
    No statistical analyses for this end point

    Secondary: Platelet Count Change From Baseline to 156 Weeks

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    End point title
    		 Platelet Count Change From Baseline to 156 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to 156 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: 10^9 cells/L
        least squares mean (confidence interval 95%)
    -3.68 (-25.15 to 17.79)
    No statistical analyses for this end point

    Secondary: Proportion of Patients With Platelet Count Normalization

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    End point title
    		 Proportion of Patients With Platelet Count Normalization
    End point description
    Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least 2 consecutive measurements which span a period of at least 4 weeks.
    End point type
    Secondary
    End point timeframe
    Through End of Study, Median Exposure 156 Weeks
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: Percentage of Participants
        number (confidence interval 95%)
    90 (68 to 99)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration

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    End point title
    		 Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration
    End point description
    PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.
    End point type
    Secondary
    End point timeframe
    Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.
    End point values
    		 eculizumab
    Number of subjects analysed
    20
    Units: microgram(s)/millilitre
    arithmetic mean (standard deviation)
        max concentration during induction period
    161.47 ( 27.29 )
        max concentration during maintenance
    427.48 ( 67.54 )
        min concentration during induction period
    112.43 ( 16.98 )
        min concentration during maintenance
    212.45 ( 53.75 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
    Adverse event reporting additional description
    At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    eculizumab
    Reporting group description
    		 All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

    Serious adverse events
    		 eculizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 20 (65.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal cell carcinoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vein disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Catheter removal
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Limb operation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Medical device complication
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Amyloidosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Impaired gastric emptying
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis E
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Q fever
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 eculizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Angiomyolipoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Benign breast neoplasm
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Lipoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Melanocytic naevus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin papilloma
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Vascular disorders
    Arterial haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Arterial occlusive disease
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Haematoma
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    9 / 20 (45.00%)
         occurrences all number
    9
    Hypotension
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Orthostatic hypotension
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Vein disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Venous thrombosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Surgical and medical procedures
    Arteriovenous fistula operation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hip arthroplasty
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Chest pain
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Extravasation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Hypothermia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Infusion site extravasation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Infusion site swelling
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Injection site haematoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Localised oedema
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Medical device complication
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Oedema
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    6
    Pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Polyp
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    7
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Seasonal allergy
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Breast swelling
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Menorrhagia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Oedema genital
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ovarian cyst
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Lung consolidation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Productive cough
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Pulmonary congestion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Investigations
    Basophil count increased
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Blood creatine increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood parathyroid hormone increased
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Blood potassium increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood pressure abnormal
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Cardiac murmur
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Eosinophil count increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Haptoglobin increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Monocyte count increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Reticulocyte count increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    White blood cell count increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    White blood cells urine positive
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Arteriovenous fistula site complication
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Corneal abrasion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Excoriation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Foreign body
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Head injury
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Hip fracture
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Humerus fracture
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Limb injury
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Scratch
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Wound
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Wrist fracture
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Cardiac disorders
    Hypertensive heart disease
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Cerebral microangiopathy
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    11 / 20 (55.00%)
         occurrences all number
    11
    Myoclonus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Paresis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Abnormal clotting factor
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Anaemia folate deficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    7
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Leukopenia
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Lymph node pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Lymphopenia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Microcytosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Splenomegaly
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Deafness bilateral
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ear pain
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Motion sickness
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Tinnitus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Vertigo
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Eye disorders
    Eye irritation Conjunctival haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 20 (25.00%)
         occurrences all number
    5
    Abdominal pain upper
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Abdominal pain lower
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Abdominal rigidity
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Aphthous stomatitis
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Ascites
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Crohn’s disease
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    10 / 20 (50.00%)
         occurrences all number
    10
    Flatulence
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gingival hyperplasia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gingival ulceration
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Impaired gastric emptying
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Malaena
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    10 / 20 (50.00%)
         occurrences all number
    10
    Subileus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Tooth impacted
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Umbilical hernia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    10 / 20 (50.00%)
         occurrences all number
    10
    Medical device pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Chest discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hepatocellular injury
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blister
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Dermatitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ecchymosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Heat rash
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Psoriasis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Rash macular
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin fissures
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Nephrolithiasis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Pollakiuria
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Proteinuria
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Renal failure
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Renal impairment
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Renal failure acute
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    6
    Bone pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Groin pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Muscular weakness
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Osteoporosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Tendon disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Tendonitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Infections and infestations
    Ateriovenous fistula site infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    BK virus infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Bacteraemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Bronchitis
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Erythrasma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Fungal infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Herpes zoster
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Infection
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Localised infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    12 / 20 (60.00%)
         occurrences all number
    12
    Otitis media
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Post procedural infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 20 (40.00%)
         occurrences all number
    8
    Urinary tract infection
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Vaginal infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Viral pharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Alkalosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Cachexia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Decreased appetite
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Dehydration
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Fluid overload
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Hyponatraemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Malnutrition
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Musculoskeletal pain
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Sep 2009
    Global modification to clinical study protocol, in particular, to: - provide a justification for the selected dosing regimen in aHUS as compared to the experience with eculizumab in PNH - correct the eculizumab dose prior to any FFP intervention based on modeling data - update certain entry criteria by adding wash out periods instead of total exclusion based on current standards of care - introduce antibiotic coverage for patients that are post transplant and on immunosuppressive treatment and/or aggressive plasma therapy - align protocol with European Summary of Product Characteristics, in particular requirements pertaining to contraception methods and hypersensitivity to eculizumab, murine proteins or to excipients - define the extension period to allow patients to continue to receive the investigational product while pending access to licensed product
    01 Sep 2010
    Global change to the clinical trial protocol to make some clarifications with regards to the ADAMTS13 activity exclusion cut-off value, and intended statistical tests.

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23738544
    For support, Contact us.
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