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

    Summary
    EudraCT number
    		 2008-006952-23
    Trial protocol
    		 DE   NL   SE   AT   FR   ES   GB   IT  
    Global end of trial date
    17 Oct 2011

    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
    C08-002A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00844545
    WHO universal trial number (UTN)
    		 -
    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
    01 Jul 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Oct 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.
    Protection of trial subjects
    Patients must have been vaccinated at least 14 days prior to receiving the first dose of eculizumab, or be vaccinated and receive treatment with appropriate antibiotics until 14 days after the vaccination.
    Background therapy
    		 No background therapy was used in this trial.
    Evidence for comparator
    		 Each 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
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    17
    EEA total number of subjects
    10
    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)
    1
    Adults (18-64 years)
    15
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Results from Study C08-002A were combined with results from another study, Study C08-002B. Study C08-002A (2008-006952-23) was conducted in adults (n=16) and Study C08-002B (2008-006953-41) was conducted in adolescents (n=1). Combined results from these 2 studies are reported here.

    Pre-assignment
    Screening details
    		 Patients had to exhibit a decrease in platelet count despite at least 4 Plasma Therapy (PT) treatments in the 1 week immediately prior to screening. Patients who met the eligibility criteria during screening were enrolled into the Treatment Period which commenced with the first eculizumab dose.

    Pre-assignment period milestones
    Number of subjects started
    		 17
    Number of subjects completed
    		 17

    Period 1
    Period 1 title
    Treatment Period (26 Weeks)
    Is this the baseline period?
    		 Yes
    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 17 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.

    Number of subjects in period 1
    		Eculizumab
    Started
    17
    Completed
    15
    Not completed
    2
         Adverse event, non-fatal
    1
         Protocol deviation
    1
    Period 2
    Period 2 title
    Extension Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Eculizumab
    Arm description
    		 Long-term follow-up of patients receiving eculizumab
    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 2 [1]
    		Eculizumab
    Started
    13
    Completed
    11
    Not completed
    2
         Adverse event, non-fatal
    2
    Notes
    [1] - 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: This extension treatment period is open to patients willing to continue to receive eculizumab until the product is registered and available. 13 patients out of the 17 that were enrolled entered this extension treatment period.
    Period 3
    Period 3 title
    Post Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Post-treatment arm
    Arm description
    		 Patients who discontinued eculizumab treatment at any time during the study were followed for 8 weeks after discontinuing eculizumab treatment.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [2]
    		Post-treatment arm
    Started
    6
    Completed
    5
    Not completed
    1
         Consent withdrawn by subject
    1
    Notes
    [2] - 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: This period is open only to patients who discontinued eculizumab at any time during the study. 6 patients out of the 17 patients who received eculizumab discontinued treatment and entered this post-treatment period.

    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 17 patients who were treated with study drug were included in the ITT population.

    Reporting group values
    		 Eculizumab Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.8 ± 13.32 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 5 5
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 1 1
        White
    		 15 15
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Platelet Category
    Units: Subjects
        < 150 x10^9/L
    		 15 15
        >= 150 x10^9/L
    		 2 2
    LDH category
    Units: Subjects
        > ULN
    		 10 10
        <= ULN
    		 7 7
    eGFR category
    Units: Subjects
        < 15
    		 7 7
        15 ≤ 30
    		 5 5
        30 ≤ 45
    		 4 4
        45 ≤ 60
    		 1 1
    CKD
    Units: Subjects
        Stage 3a
    		 1 1
        Stage 3b
    		 4 4
        Stage 4
    		 5 5
        Stage 5
    		 7 7
    Platelet count
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 109.03 ± 32.07 -
    LDH
    Units: U/L
        arithmetic mean (standard deviation)
    		 322.5 ± 138.15 -
    Creatinine
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    		 351.5 ± 214.92 -
    eGFR
    Units: mL/min/1.73*m^2
        arithmetic mean (standard deviation)
    		 22.9 ± 14.54 -

    End points

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    End points 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 17 patients who were treated with study drug were included in the ITT population.
    Reporting group title
    Eculizumab
    Reporting group description
    		 Long-term follow-up of patients receiving eculizumab
    Reporting group title
    Post-treatment arm
    Reporting group description
    		 Patients who discontinued eculizumab treatment at any time during the study were followed for 8 weeks after discontinuing eculizumab treatment.

    Primary: Platelet Count Change From Baseline to 26 Weeks

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    End point title
    		 Platelet Count Change From Baseline to 26 Weeks [1]
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to 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 trial is a single arm trial and the system dose not support statistical analyses for single arm trial.
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: 10^9 cells/L
        least squares mean (confidence interval 95%)
    65.18 (37.01 to 93.36)
    No statistical analyses for this end point

    Primary: Proportion of Patients With Platelet Count Normalization

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    End point title
    		 Proportion of Patients With Platelet Count Normalization [2]
    End point description
    The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span 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 trial is a single arm trial and the system dose not support statistical analyses for single arm trial.
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: Percentage of Participants
        number (confidence interval 95%)
    82 (57 to 96)
    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 [3]
    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
    [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 trial is a single arm trial and the system dose not support statistical analyses for single arm trial.
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: Percentage of Participants
        number (confidence interval 95%)
    76 (50 to 93)
    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 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
    Secondary
    End point timeframe
    Through 26 weeks
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: Percentage of Participants
        number (confidence interval 95%)
    65 (38 to 86)
    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
    17
    Units: # events/patient/day
        arithmetic mean (standard deviation)
    0.04 ± 0.1
    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
    17
    Units: 10^9 cells/L
        least squares mean (confidence interval 95%)
    111.62 (98.12 to 125.13)
    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 two consecutive measurements which span a period of at least four weeks.
    End point type
    Secondary
    End point timeframe
    Through End of Study, Median Exposure 100.29 Weeks
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: Percentage of Participants
        number (confidence interval 95%)
    88 (64 to 99)
    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
    End point type
    Secondary
    End point timeframe
    Through End of Study, Median Exposure 100.29 Weeks
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: Percentage of Participants
        number (confidence interval 95%)
    88 (64 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 the study 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 100.29 Weeks
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: Percentage of Participants
        number (confidence interval 95%)
    76 (50 to 93)
    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 the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the 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 100.29 Weeks
    End point values
    		 Eculizumab
    Number of subjects analysed
    17
    Units: # events/patient/day
        arithmetic mean (standard deviation)
    0.04 ± 0.11
    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
    17
    Units: microgram(s)/millilitre
    arithmetic mean (standard deviation)
        max concentration during induction period
    145.16 ± 26.56
        min concentration during induction period
    93.66 ± 22.1
        max concentration during maintenance
    345.14 ± 89.74
        min concentration during maintenance
    151.8 ± 68.16
    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 100 weeks and ranged from two weeks to 186 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
    17 / 17 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Embolism venous
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
         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 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Respiratory fume inhalation disorder
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         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
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 17 (5.88%)
         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 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal impairment
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 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
    17 / 17 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Hypertension
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    8
    Hypotension
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Orthostatic hypotension
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Poor venous access
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Chest discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Cyst
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Face oedema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Influenza like illness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    5
    Pain
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    4
    Tenderness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Thirst
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Seasonal allergy
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Breast calcifications
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cervical dysplasia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Menorrhagia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Metrorrhagia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Ovarian cyst
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Uterine malposition
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Emphysema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Nasal congestion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nasal septum deviation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Pleural effusion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Productive cough
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Sinus congestion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dysthymic disorder
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Nervousness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Sleep disorder
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Investigations
    Antibiotic resistant Staphylococcus test positive
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Carbon dioxide abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Haematocrit decreased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Haptoglobin decreased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Reticulocyte count increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vitamin D decreased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arteriovenous fistula aneurysm
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Excoriation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye injury
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Incision site oedema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Muscle rupture
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vascular graft complication
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Pericardial effusion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    7
    Lethargy
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Loss of consciousness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Sinus headache
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    6
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Leukopenia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    4
    Lymphopenia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vertigo
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Photophobia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dental caries
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    8 / 17 (47.06%)
         occurrences all number
    8
    Food poisoning
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Glossodynia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Impaired gastric emptying
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    5
    Oral pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Vomiting
         subjects affected / exposed
    8 / 17 (47.06%)
         occurrences all number
    8
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hepatocellular injury
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dermatitis contact
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Dry skin
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Erythema
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Increased tendency to bruise
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Skin depigmentation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin disorder
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin irritation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin lesion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Haematuria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Nephropathy toxic
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pollakiuria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Proteinuria
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Renal failure acute
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Renal impairment
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    5
    Renal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hyperparathyroidism secondary
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hypothalamo-pituitary disorder
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Bone pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Muscle spasms
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Osteopenia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tendonitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Campylobacter infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Fungal infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Genital herpes
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Haemophilus infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Impetigo
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Onychomycosis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Papilloma viral infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Sinusitis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Staphylococcal infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Tooth infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tracheobronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    5
    Urinary tract infection
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    6
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Dehydration
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dyslipidaemia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Fluid overload
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Fluid retention
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hyperphosphataemia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Hyperlipidaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Hypomagnesaemia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Iron deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Obesity
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    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
    Protocol version 2.0
    26 Aug 2010
    Protocol version 3.0

    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
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