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    Clinical Trial Results:
    A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies

    Summary
    EudraCT number
    2012-000578-41
    Trial protocol
    DE  
    Global end of trial date
    09 Feb 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Feb 2019
    First version publication date
    07 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GX28198
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01602120
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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
    09 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the long-term ocular and systemic safety and tolerability of lampalizumab administered intravitreally (ITV), monthly.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 147
    Country: Number of subjects enrolled
    Germany: 12
    Worldwide total number of subjects
    159
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2
    From 65 to 84 years
    120
    85 years and over
    37

    Subject disposition

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    Recruitment
    Recruitment details
    This study enrolled eligible patients who had completed the 18-month treatment period of Study NCT01229215 (CFD4870g) or the 24-week treatment period of Study NCT02288559 (GX29455). This study was terminated early by the Sponsor due to lack of efficacy.

    Pre-assignment
    Screening details
    This study enrolled subjects with geographic atrophy at 43 study sites in two countries.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CFD4870g Sham
    Arm description
    Subjects who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.
    Arm type
    Experimental

    Investigational medicinal product name
    Lampalizumab
    Investigational medicinal product code
    RO5490249
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Lampalizumab was administered at a dose of 10 mg as an ITV injection, starting at the Day 1 visit, Q4W or Q6W, for approximately 96 weeks.

    Arm title
    CFD4870g Lampalizumab
    Arm description
    Subjects received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.
    Arm type
    Experimental

    Investigational medicinal product name
    Lampalizumab
    Investigational medicinal product code
    RO5490249
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Lampalizumab was administered at a dose of 10 mg as an ITV injection, starting at the Day 1 visit, Q4W or Q6W, for approximately 96 weeks.

    Arm title
    GX29455 Sham
    Arm description
    Subjects who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
    Arm type
    Experimental

    Investigational medicinal product name
    Lampalizumab
    Investigational medicinal product code
    RO5490249
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Lampalizumab was administered at a dose of 10 mg as an ITV injection, starting at the Day 1 visit, Q4W, for approximately 54 months.

    Arm title
    GX29455 Lampalizumab
    Arm description
    Subject who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
    Arm type
    Experimental

    Investigational medicinal product name
    Lampalizumab
    Investigational medicinal product code
    RO5490249
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Lampalizumab was administered at a dose of 10 mg as an ITV injection, starting at the Day 1 visit, Q4W, for approximately 54 months.

    Number of subjects in period 1
    CFD4870g Sham CFD4870g Lampalizumab GX29455 Sham GX29455 Lampalizumab
    Started
    29
    60
    17
    53
    Completed
    0
    0
    0
    0
    Not completed
    29
    60
    17
    53
         Unspecified Reason
    3
    1
    -
    2
         Consent withdrawn by subject
    8
    17
    -
    3
         Physician decision
    2
    3
    -
    -
         Adverse Event
    3
    6
    -
    2
         Death
    -
    4
    -
    -
         Non-compliance
    -
    3
    -
    1
         Study Terminated by Sponsor
    12
    24
    17
    44
         Lost to follow-up
    -
    1
    -
    1
         Protocol deviation
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CFD4870g Sham
    Reporting group description
    Subjects who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.

    Reporting group title
    CFD4870g Lampalizumab
    Reporting group description
    Subjects received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.

    Reporting group title
    GX29455 Sham
    Reporting group description
    Subjects who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.

    Reporting group title
    GX29455 Lampalizumab
    Reporting group description
    Subject who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.

    Reporting group values
    CFD4870g Sham CFD4870g Lampalizumab GX29455 Sham GX29455 Lampalizumab Total
    Number of subjects
    29 60 17 53 159
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    79.4 ± 6.6 79.4 ± 6.8 76.7 ± 6.6 79.5 ± 7.6 -
    Sex: Female, Male
    Units: Subjects
        Female
    17 33 12 27 89
        Male
    12 27 5 26 70

    End points

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    End points reporting groups
    Reporting group title
    CFD4870g Sham
    Reporting group description
    Subjects who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.

    Reporting group title
    CFD4870g Lampalizumab
    Reporting group description
    Subjects received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.

    Reporting group title
    GX29455 Sham
    Reporting group description
    Subjects who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.

    Reporting group title
    GX29455 Lampalizumab
    Reporting group description
    Subject who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.

    Subject analysis set title
    All Subjects
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects in the study received lampalizumab 10 mg, ITV, Q4W.

    Primary: Percentage of Subjects With Ocular and Non-ocular Adverse Events (AEs)

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    End point title
    Percentage of Subjects With Ocular and Non-ocular Adverse Events (AEs) [1]
    End point description
    An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events. Safety population included all subjects who were enrolled and received at least one lampalizumab injection in the extension study.
    End point type
    Primary
    End point timeframe
    From Day 1 through the last study visit (up to approximately 62 months)
    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: Descriptive statistics only
    End point values
    CFD4870g Sham CFD4870g Lampalizumab GX29455 Sham GX29455 Lampalizumab All Subjects
    Number of subjects analysed
    29
    60
    17
    53
    159
    Units: percentage of subjects
    number (not applicable)
        Ocular AEs in Study Eye
    62.1
    78.3
    52.9
    50.9
    63.5
        Ocular AEs in Fellow Eye
    62.1
    68.3
    29.4
    60.4
    60.4
        Non-Ocular AEs
    79.3
    90.0
    82.4
    67.9
    79.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 through the last study visit (up to approximately 62 months)
    Adverse event reporting additional description
    If the subject had any ongoing adverse events from Study CFD4870g or GX29455 at time of enrolment the events were counted in this Study. Safety population: all subjects who were enrolled and received at least one lampalizumab injection in this study. The arm All Subjects represents the total number of adverse events in the four arms of the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    CFD4870g Sham
    Reporting group description
    Subjects who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.

    Reporting group title
    CFD4870g Lampalizumab
    Reporting group description
    Subjects received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.

    Reporting group title
    GX29455 Sham
    Reporting group description
    Subjects who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.

    Reporting group title
    GX29455 Lampalizumab
    Reporting group description
    Subjects who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.

    Reporting group title
    All Subjects
    Reporting group description
    All subjects in the study received lampalizumab 10 mg, ITV, Q4W.

    Serious adverse events
    CFD4870g Sham CFD4870g Lampalizumab GX29455 Sham GX29455 Lampalizumab All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 29 (55.17%)
    40 / 60 (66.67%)
    5 / 17 (29.41%)
    9 / 53 (16.98%)
    70 / 159 (44.03%)
         number of deaths (all causes)
    1
    6
    0
    1
    8
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Bladder cancer
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Breast cancer
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Lung carcinoma cell type unspecified stage III
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Meningioma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Fatigue
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corneal abrasion
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital injury
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 29 (0.00%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 29 (0.00%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    Cardiac perforation
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricle rupture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blindness transient
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 60 (3.33%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 2
    0 / 0
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitritis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    6 / 159 (3.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    CFD4870g Sham CFD4870g Lampalizumab GX29455 Sham GX29455 Lampalizumab All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 29 (82.76%)
    56 / 60 (93.33%)
    16 / 17 (94.12%)
    41 / 53 (77.36%)
    137 / 159 (86.16%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 60 (3.33%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    6 / 159 (3.77%)
         occurrences all number
    5
    7
    1
    0
    13
    Benign neoplasm of skin
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    6
    1
    0
    0
    7
    Blepharal papilloma
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    0
    4
    0
    0
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 29 (6.90%)
    7 / 60 (11.67%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    11 / 159 (6.92%)
         occurrences all number
    2
    7
    1
    1
    11
    Hypotension
         subjects affected / exposed
    0 / 29 (0.00%)
    4 / 60 (6.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    0
    4
    1
    0
    5
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    2
    0
    2
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    2 / 53 (3.77%)
    8 / 159 (5.03%)
         occurrences all number
    2
    3
    1
    2
    8
    Pain
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    1
    3
    0
    0
    4
    Asthenia
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    0
    3
    0
    0
    3
    Injection site pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    2
    3
    0
    0
    5
    Drug hypersensitivity
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    0
    4
    0
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    8 / 159 (5.03%)
         occurrences all number
    3
    6
    0
    1
    10
    Dyspnoea
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    5 / 159 (3.14%)
         occurrences all number
    0
    3
    1
    1
    5
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 60 (3.33%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    2
    2
    1
    0
    5
    Oropharyngeal pain
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    3 / 159 (1.89%)
         occurrences all number
    2
    0
    0
    1
    3
    Sinus congestion
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    6 / 159 (3.77%)
         occurrences all number
    1
    4
    0
    1
    6
    Anxiety
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    5 / 159 (3.14%)
         occurrences all number
    0
    3
    0
    2
    5
    Hallucination, visual
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    0
    2
    1
    0
    3
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    3 / 29 (10.34%)
    6 / 60 (10.00%)
    0 / 17 (0.00%)
    3 / 53 (5.66%)
    12 / 159 (7.55%)
         occurrences all number
    4
    13
    0
    3
    20
    Blood glucose increased
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    7 / 29 (24.14%)
    13 / 60 (21.67%)
    3 / 17 (17.65%)
    2 / 53 (3.77%)
    25 / 159 (15.72%)
         occurrences all number
    12
    18
    3
    3
    36
    Contusion
         subjects affected / exposed
    0 / 29 (0.00%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    6 / 159 (3.77%)
         occurrences all number
    0
    6
    0
    1
    7
    Procedural pain
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    6 / 159 (3.77%)
         occurrences all number
    1
    5
    0
    0
    6
    Corneal abrasion
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    1
    5
    0
    0
    6
    Laceration
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    0
    6
    1
    0
    7
    Ligament sprain
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    0
    3
    2
    0
    5
    Rib fracture
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    1
    3
    0
    0
    4
    Muscle strain
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    0
    3
    0
    0
    3
    Skin abrasion
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    3 / 159 (1.89%)
         occurrences all number
    2
    0
    0
    1
    3
    Foot fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Forearm fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 29 (6.90%)
    10 / 60 (16.67%)
    1 / 17 (5.88%)
    2 / 53 (3.77%)
    15 / 159 (9.43%)
         occurrences all number
    2
    10
    3
    2
    17
    Coronary artery disease
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    1
    4
    0
    0
    5
    Cardiac failure congestive
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    4 / 159 (2.52%)
         occurrences all number
    0
    3
    0
    1
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 29 (3.45%)
    8 / 60 (13.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    9 / 159 (5.66%)
         occurrences all number
    1
    12
    0
    0
    13
    Dementia
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    5 / 159 (3.14%)
         occurrences all number
    1
    3
    0
    1
    5
    Dizziness
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 60 (3.33%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    4 / 159 (2.52%)
         occurrences all number
    0
    2
    1
    1
    4
    Neuropathy peripheral
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 60 (3.33%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    2
    2
    1
    0
    5
    Paraesthesia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    2
    0
    0
    0
    2
    Migraine
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    2 / 53 (3.77%)
    6 / 159 (3.77%)
         occurrences all number
    3
    1
    1
    2
    7
    Leukocytosis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    4 / 29 (13.79%)
    18 / 60 (30.00%)
    3 / 17 (17.65%)
    3 / 53 (5.66%)
    28 / 159 (17.61%)
         occurrences all number
    5
    47
    3
    4
    59
    Retinal haemorrhage
         subjects affected / exposed
    4 / 29 (13.79%)
    13 / 60 (21.67%)
    2 / 17 (11.76%)
    3 / 53 (5.66%)
    22 / 159 (13.84%)
         occurrences all number
    9
    21
    2
    3
    35
    Eye pain
         subjects affected / exposed
    3 / 29 (10.34%)
    14 / 60 (23.33%)
    0 / 17 (0.00%)
    4 / 53 (7.55%)
    21 / 159 (13.21%)
         occurrences all number
    5
    22
    0
    6
    33
    Cataract
         subjects affected / exposed
    1 / 29 (3.45%)
    9 / 60 (15.00%)
    0 / 17 (0.00%)
    5 / 53 (9.43%)
    15 / 159 (9.43%)
         occurrences all number
    1
    17
    0
    6
    24
    Posterior capsule opacification
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 60 (5.00%)
    2 / 17 (11.76%)
    5 / 53 (9.43%)
    13 / 159 (8.18%)
         occurrences all number
    5
    4
    2
    5
    16
    Vitreous detachment
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    6 / 53 (11.32%)
    12 / 159 (7.55%)
         occurrences all number
    8
    2
    0
    8
    18
    Vitreous floaters
         subjects affected / exposed
    2 / 29 (6.90%)
    6 / 60 (10.00%)
    1 / 17 (5.88%)
    3 / 53 (5.66%)
    12 / 159 (7.55%)
         occurrences all number
    3
    10
    2
    4
    19
    Dry eye
         subjects affected / exposed
    1 / 29 (3.45%)
    6 / 60 (10.00%)
    0 / 17 (0.00%)
    4 / 53 (7.55%)
    11 / 159 (6.92%)
         occurrences all number
    2
    10
    0
    8
    20
    Punctate keratitis
         subjects affected / exposed
    1 / 29 (3.45%)
    7 / 60 (11.67%)
    2 / 17 (11.76%)
    1 / 53 (1.89%)
    11 / 159 (6.92%)
         occurrences all number
    3
    13
    3
    2
    21
    Visual impairment
         subjects affected / exposed
    0 / 29 (0.00%)
    5 / 60 (8.33%)
    1 / 17 (5.88%)
    3 / 53 (5.66%)
    9 / 159 (5.66%)
         occurrences all number
    0
    8
    1
    5
    14
    Cataract nuclear
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    4 / 53 (7.55%)
    8 / 159 (5.03%)
         occurrences all number
    2
    4
    0
    6
    12
    Blepharitis
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    7 / 159 (4.40%)
         occurrences all number
    2
    14
    0
    4
    20
    Neovascular age−related macular degeneration
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    7 / 159 (4.40%)
         occurrences all number
    2
    3
    1
    1
    7
    Vision blurred
         subjects affected / exposed
    3 / 29 (10.34%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    7 / 159 (4.40%)
         occurrences all number
    7
    5
    0
    0
    12
    Iritis
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    6 / 159 (3.77%)
         occurrences all number
    1
    5
    2
    0
    8
    Blindness transient
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    3
    4
    0
    0
    7
    Cataract subcapsular
         subjects affected / exposed
    0 / 29 (0.00%)
    4 / 60 (6.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    0
    5
    1
    0
    6
    Dry age−related macular degeneration
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    5 / 159 (3.14%)
         occurrences all number
    2
    2
    0
    1
    5
    Eye pruritus
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    1
    4
    2
    0
    7
    Lacrimation increased
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    5 / 159 (3.14%)
         occurrences all number
    3
    2
    0
    4
    9
    Ocular hyperaemia
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    5 / 159 (3.14%)
         occurrences all number
    1
    5
    0
    1
    7
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    1
    3
    0
    0
    4
    Visual acuity reduced
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    4 / 159 (2.52%)
         occurrences all number
    3
    1
    0
    1
    5
    Blepharochalasis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    3 / 53 (5.66%)
    3 / 159 (1.89%)
         occurrences all number
    0
    0
    0
    8
    8
    Conjunctival hyperaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    2
    1
    0
    0
    3
    Ocular hypertension
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    3 / 53 (5.66%)
    3 / 159 (1.89%)
         occurrences all number
    0
    0
    0
    3
    3
    Open angle glaucoma
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    3 / 159 (1.89%)
         occurrences all number
    2
    0
    2
    1
    5
    Trichiasis
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    9
    1
    0
    0
    10
    Corneal erosion
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    4
    0
    0
    0
    4
    Corneal opacity
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    0
    1
    2
    0
    3
    Vitreous haemorrhage
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 60 (0.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    2
    0
    0
    0
    2
    Corneal oedema
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Eyelid ptosis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Macular oedema
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 29 (6.90%)
    9 / 60 (15.00%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    13 / 159 (8.18%)
         occurrences all number
    2
    9
    1
    1
    13
    Diarrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    7 / 60 (11.67%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    10 / 159 (6.29%)
         occurrences all number
    1
    9
    0
    2
    12
    Nausea
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    8 / 159 (5.03%)
         occurrences all number
    1
    6
    0
    2
    9
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    7 / 159 (4.40%)
         occurrences all number
    2
    5
    0
    0
    7
    Gastritis
         subjects affected / exposed
    0 / 29 (0.00%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    0
    6
    0
    0
    6
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 60 (1.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    2
    1
    0
    0
    3
    Hyperkeratosis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    1
    0
    1
    0
    2
    Skin ulcer
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    2
    0
    1
    0
    3
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    1
    5
    0
    0
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 60 (8.33%)
    1 / 17 (5.88%)
    2 / 53 (3.77%)
    9 / 159 (5.66%)
         occurrences all number
    1
    7
    1
    2
    11
    Back pain
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    8 / 159 (5.03%)
         occurrences all number
    2
    4
    0
    2
    8
    Arthritis
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    7 / 159 (4.40%)
         occurrences all number
    4
    3
    1
    0
    8
    Pain in extremity
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 60 (6.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    7 / 159 (4.40%)
         occurrences all number
    2
    4
    1
    0
    7
    Musculoskeletal pain
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    6 / 159 (3.77%)
         occurrences all number
    3
    2
    0
    1
    6
    Osteoporosis
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    5 / 159 (3.14%)
         occurrences all number
    0
    3
    1
    1
    5
    Sjogren’s syndrome
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    0
    5
    0
    0
    5
    Foot deformity
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    0
    1
    1
    0
    2
    Bone swelling
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Metatarsalgia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 60 (0.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 29 (27.59%)
    11 / 60 (18.33%)
    1 / 17 (5.88%)
    4 / 53 (7.55%)
    24 / 159 (15.09%)
         occurrences all number
    17
    27
    2
    5
    51
    Urinary tract infection
         subjects affected / exposed
    3 / 29 (10.34%)
    13 / 60 (21.67%)
    1 / 17 (5.88%)
    4 / 53 (7.55%)
    21 / 159 (13.21%)
         occurrences all number
    6
    17
    1
    6
    30
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 29 (13.79%)
    9 / 60 (15.00%)
    3 / 17 (17.65%)
    4 / 53 (7.55%)
    20 / 159 (12.58%)
         occurrences all number
    5
    14
    3
    4
    26
    Bronchitis
         subjects affected / exposed
    5 / 29 (17.24%)
    7 / 60 (11.67%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    14 / 159 (8.81%)
         occurrences all number
    6
    8
    0
    2
    16
    Sinusitis
         subjects affected / exposed
    4 / 29 (13.79%)
    5 / 60 (8.33%)
    1 / 17 (5.88%)
    1 / 53 (1.89%)
    11 / 159 (6.92%)
         occurrences all number
    6
    8
    1
    1
    16
    Pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    6 / 60 (10.00%)
    1 / 17 (5.88%)
    2 / 53 (3.77%)
    9 / 159 (5.66%)
         occurrences all number
    0
    8
    1
    2
    11
    Herpes zoster
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    2 / 53 (3.77%)
    7 / 159 (4.40%)
         occurrences all number
    1
    4
    0
    2
    7
    Influenza
         subjects affected / exposed
    0 / 29 (0.00%)
    6 / 60 (10.00%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    7 / 159 (4.40%)
         occurrences all number
    0
    6
    1
    0
    7
    Cystitis
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    5 / 159 (3.14%)
         occurrences all number
    1
    5
    0
    1
    7
    Ear infection
         subjects affected / exposed
    0 / 29 (0.00%)
    4 / 60 (6.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    5 / 159 (3.14%)
         occurrences all number
    0
    4
    1
    0
    5
    Conjunctivitis
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    2
    4
    0
    0
    6
    Tooth infection
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    1
    3
    0
    0
    4
    Cellulitis
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    2
    1
    1
    0
    4
    Diverticulitis
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 60 (5.00%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    0
    5
    0
    0
    5
    Oral herpes
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    0
    1
    1
    0
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    5 / 60 (8.33%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    6 / 159 (3.77%)
         occurrences all number
    0
    5
    0
    1
    6
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 60 (3.33%)
    0 / 17 (0.00%)
    1 / 53 (1.89%)
    5 / 159 (3.14%)
         occurrences all number
    2
    2
    0
    1
    5
    Hyperlipidaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    4 / 60 (6.67%)
    0 / 17 (0.00%)
    0 / 53 (0.00%)
    4 / 159 (2.52%)
         occurrences all number
    0
    4
    0
    0
    4
    Diabetes mellitus
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 60 (1.67%)
    1 / 17 (5.88%)
    0 / 53 (0.00%)
    3 / 159 (1.89%)
         occurrences all number
    1
    1
    1
    0
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Sep 2013
    Study was amended to ensure that subjects received the most efficacious treatment. Consequently, subjects in the lampalizumab every–other-month treatment group were crossed over to the lampalizumab monthly treatment group. Subjects who declined to provide informed consent for crossover to the monthly group were discontinued from the study. In addition, the treatment period was extended by 24 months to create a revised treatment period of 42 months, total. As of 11 April 2013, FCFD4514S received an International Nonproprietary Name of “lampalizumab” and referred to in the text as such. In some figure legends, study titles, and appendices, the name “FCFD4514S” might still be referenced and should be read as synonymous with lampalizumab. An optional, single, whole-blood sample was collected at German sites, at any timepoint, for genotyping analysis. A one-time, subject-reported height and weight was obtained at any point during the study.
    25 Jun 2015
    Study was amended to include a cohort of subjects with geographic atrophy secondary to age related macular degeneration who had completed the Genentech−sponsored Study NCT02288559 (GX29455). This cohort of subjects undertook the same assessments at the same timepoint as the rest of the subjects enrolled to Study GX28198, according to schedule of assessments and received monthly study treatment with 10 milligrams (mg) of lampalizumab. The study duration was expanded by 24 months for a total duration of 66 months. At the discretion of the investigator, enrolled subjects who were receiving study treatment and are diagnosed with choroidal neovascularization in either eye treated with ranibizumab. The Section "Safety" was updated to reflect the current protocol standard and safety program for lampalizumab. The investigator requirements section was updated to reflect the current protocol standard. The inclusion criterion around contraception was updated to be consistent with 2014 Clinical Trial Facilitation Group recommendations.
    18 May 2017
    The study duration was extended an additional 30 months to provide study subjects with access to treatment until potential commercialisation of lampalizumab; total study duration was now 96 months. Table 1 (Dosing Schema) was updated to clarify that no study treatment was administered at the early termination visit. Clarifying language was added to Section “All Extension Study Patients” regarding unscheduled safety assessment visits in the event of new ocular symptoms after injection. Language was added to clarify the rationale for the crossover to monthly treatment in Study NCT01229215 (CFD4870g). The safety plan was updated to reflect the current safety information for lampalizumab. Section “Patient Selection” was updated to include a notation regarding administration of the first intravitreal (ITV) injection of lampalizumab. The language was modified to reflect updates to the protocol template in Section "Safety". Changes included, Sections “Events that Occur after Study Drug Initiation” and “Post-study Adverse Events” were revised regarding reporting in the event that the Electronic Data Capture (EDC) system was unavailable. Section “Deaths” was modified to prohibit use of the term "sudden death" on the Adverse Event electronic Case Report Form (eCRF), unless it was combined with the presumed cause of death (e.g., "sudden cardiac death"), as use of the term "sudden death" would require the Sponsor to query the site for clarification on the cause of death.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    09 Feb 2018
    The study was terminated early by the Sponsor due to lack of efficacy of the compound.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, no subject in this study completed the full duration of treatment.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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