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    Clinical Trial Results:
    HORIZON: A Phase II, open-label, outcomes-assessor masked, multicentre, randomized, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to dry age-related macular degeneration.

    Summary
    EudraCT number
    		 2020-002431-30
    Trial protocol
    		 GB   DE   FR   IE  
    Global end of trial date
    10 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2025
    First version publication date
    28 Mar 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GT005-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04566445
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor ID II: CPPY988A12201
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.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
    10 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate the effect of GT005 vs untreated control on the progression of GA in subjects with GA due to AMD Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    United States: 177
    Worldwide total number of subjects
    255
    EEA total number of subjects
    45
    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)
    10
    From 65 to 84 years
    201
    85 years and over
    44

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were enrolled at 53 centers in 7 countries: 37 centers in the United States, 2 centers in France, 4 centers in Germany, 1 center in Poland, 3 centers in Spain, 4 centers in the United Kingdom, and 2 centers in Australia. A total of 255 subjects were enrolled into the study.

    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
    		 GT005 Medium dose [5E10 vg]
    Arm description
    		 GT005 Medium dose [5E10 vg]
    Arm type
    		 Experimental

    Investigational medicinal product name
    GT005
    Investigational medicinal product code
    PPY988
    Other name
    PPY988
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    single time subretinal injection of GT005 [5E10 vg]

    Arm title
    		 GT005 High dose [2E11 vg]
    Arm description
    		 GT005 High dose [2E11 vg]
    Arm type
    		 Experimental

    Investigational medicinal product name
    GT005
    Investigational medicinal product code
    PPY988
    Other name
    PPY988
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    single time subretinal injection of GT005 [2E11 vg]

    Arm title
    		 Untreated control
    Arm description
    		 Untreated control
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Started
    87
    86
    82
    Completed
    54
    51
    35
    Not completed
    33
    35
    47
         Adverse event, serious fatal
    4
    1
    1
         Consent withdrawn by subject
    12
    14
    13
         Adverse event, non-fatal
    1
    1
    -
         Randomized but not treated due to AE
    2
    1
    -
         Study terminated by sponsor
    11
    17
    32
         Lost to follow-up
    3
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GT005 Medium dose [5E10 vg]
    Reporting group description
    		 GT005 Medium dose [5E10 vg]

    Reporting group title
    GT005 High dose [2E11 vg]
    Reporting group description
    		 GT005 High dose [2E11 vg]

    Reporting group title
    Untreated control
    Reporting group description
    		 Untreated control

    Reporting group values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control Total
    Number of subjects
    		 87 86 82 255
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 6 3 1 10
        From 65-84 years
    		 69 66 66 201
        85 years and over
    		 12 17 15 44
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 77.6 ( 7.33 ) 77.6 ( 7.60 ) 77.8 ( 6.83 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 52 61 53 166
        Male
    		 35 25 29 89
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 87 80 80 247
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 5 2 7

    End points

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    End points reporting groups
    Reporting group title
    GT005 Medium dose [5E10 vg]
    Reporting group description
    		 GT005 Medium dose [5E10 vg]

    Reporting group title
    GT005 High dose [2E11 vg]
    Reporting group description
    		 GT005 High dose [2E11 vg]

    Reporting group title
    Untreated control
    Reporting group description
    		 Untreated control

    Primary: The change from baseline to Week 72 in geographic atrophy (GA)

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    End point title
    		 The change from baseline to Week 72 in geographic atrophy (GA)
    End point description
    GA area as measured by fundus autofluorescence (FAF)
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48 and 72
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    75
    75
    72
    Units: mm2
    least squares mean (standard error)
        Week 12 (n=75,71,72)
    0.730 ( 0.0625 )
    0.752 ( 0.0634 )
    0.667 ( 0.0647 )
        Week 24 (72,75,71)
    1.151 ( 0.0833 )
    1.260 ( 0.0831 )
    1.054 ( 0.0860 )
        Week 36 (n=66,66,71)
    1.728 ( 0.1488 )
    1.955 ( 0.1503 )
    1.531 ( 0.1528 )
        Week 48 (n=64,68,65)
    2.098 ( 0.1841 )
    2.535 ( 0.1853 )
    2.047 ( 0.1896 )
        Week 72 n=56,51,54)
    3.225 ( 0.2337 )
    3.421 ( 0.2369 )
    2.919 ( 0.2412 )
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 12
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.062
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.087
         upper limit
    		 0.211
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0901
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 12
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.084
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.066
         upper limit
    		 0.234
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.091
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 24
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.096
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.102
         upper limit
    		 0.294
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1198
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 24
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.205
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.007
         upper limit
    		 0.404
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 36
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.197
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.155
         upper limit
    		 0.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2135
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 36
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.423
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.068
         upper limit
    		 0.779
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2152
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 48
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.052
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.385
         upper limit
    		 0.489
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2644
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 48
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.488
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.049
         upper limit
    		 0.928
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2662
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 72
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.307
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.248
         upper limit
    		 0.862
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3361
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 72
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.503
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.058
         upper limit
    		 1.063
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3392

    Secondary: The change from baseline at Week 96 in geographic atrophy (GA)

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    End point title
    		 The change from baseline at Week 96 in geographic atrophy (GA)
    End point description
    GA area as measured by fundus autofluorescence (FAF)
    End point type
    Secondary
    End point timeframe
    Baseline, Week 96
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    44
    39
    32
    Units: mm2
        least squares mean (standard error)
    4.414 ( 0.3109 )
    4.607 ( 0.3167 )
    3.769 ( 0.3286 )
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 96
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.838
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.081
         upper limit
    		 1.594
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4577
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 96
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.645
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.103
         upper limit
    		 1.393
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4527

    Secondary: Summary of Adverse Events

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    End point title
    		 Summary of Adverse Events
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. AE = adverse event SAE = serious adverse event Rel = related Trt = study treatment Proc. = procedure Disc. = discontinuation AESI = AE of special interest Surg. = surgical
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks.
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    87
    86
    82
    Units: Participants
        Subjects with >= 1 ocular AE for the study eye
    66
    65
    15
        Subjects with >= 1 ocular AE for the fellow eye
    32
    35
    14
        Subjects with >= 1 non-ocular AE
    63
    59
    44
        n with >= 1 ocular AE rel. to trt. - study eye
    13
    21
    0
        n with >= 1 non-ocular AE related to trt.
    0
    0
    0
        n >= 1 ocular AE rel. to surg. proc.- study eye
    48
    48
    0
        n with >= 1 non-ocular AE rela.to surgical proc.
    0
    0
    0
        n >= 1 ocular AE rel. to study proc. - study eye
    8
    9
    0
        n with >= 1 non-ocular AE related to study proc.
    0
    2
    0
        n >= 1 ocular AE leading to disc. - study eye
    0
    0
    0
        n with >= 1 non-ocular AE leading to disc.
    5
    2
    1
        Subjects with >= 1 ocular AESI for the study eye
    19
    31
    3
        n with >= 1 ocular AESI for the fellow eye
    3
    3
    1
        Subjects with >= 1 ocular SAE for the study eye
    2
    5
    0
        Subjects with >= 1 ocular SAE for the fellow eye
    0
    0
    0
        Subjects with at least one non-ocular SAE
    20
    22
    10
        n >= 1 ocular SAE rel. to trt. for the study eye
    0
    0
    0
        n >= 1 non-ocular SAE related to study trt.
    0
    0
    0
        n >= 1 ocular SAE rel. to surg proc - study eye
    1
    4
    0
        n >= 1 e non-ocular SAE rel. to surgical proc.
    0
    0
    0
        n >= 1 ocular SAE rel. to study proc - study eye
    1
    1
    0
        n >= 1 non-ocular SAE related to study proc.
    0
    0
    0
        n >= 1 ocular SAE leading to disc.- study eye
    0
    0
    0
        n with >= 1 non-ocular SAE leading to disc.
    5
    2
    1
        Deaths
    4
    1
    1
    No statistical analyses for this end point

    Secondary: Ocular AEs occurring in ≥2% of subjects by primary system organ class and preferred term for the study eye

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    End point title
    		 Ocular AEs occurring in ≥2% of subjects by primary system organ class and preferred term for the study eye
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks.
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    87
    86
    82
    Units: Participants
        Subjects with at least one event
    66
    65
    15
        Eye disorders
    65
    62
    14
        -Cataract
    21
    20
    3
        -Retinal pigmentation
    12
    22
    0
        -Conjunctival haemorrhage
    18
    12
    1
        -Retinal haemorrhage
    8
    10
    2
        -Eye pain
    5
    7
    0
        -Ocular hypertension
    6
    6
    0
        -Punctate keratitis
    6
    6
    0
        -Retinal tear
    5
    6
    0
        -Dry eye
    4
    4
    1
        -Posterior capsule opacification
    3
    4
    2
        -Anterior chamber cell
    4
    4
    0
        -Eye irritation
    6
    2
    0
        -Vitreous haemorrhage
    2
    6
    0
        -Choroidal neovascularisation
    2
    3
    2
        -Vitreous floaters
    3
    4
    0
        -Cataract nuclear
    3
    3
    0
        -Retinal detachment
    2
    4
    0
        -Corneal oedema
    1
    4
    0
        -Diplopia
    4
    1
    0
        -Eye pruritus
    1
    4
    0
        -Foreign body sensation in eyes
    3
    2
    0
        -Iritis
    4
    1
    0
        -Visual impairment
    2
    3
    0
        Investigations
    11
    2
    0
        -Intraocular pressure increased
    1
    2
    0
    No statistical analyses for this end point

    Secondary: Non-ocular AEs occurring in ≥2% of subjects

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    End point title
    		 Non-ocular AEs occurring in ≥2% of subjects
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks.
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    87
    86
    82
    Units: Participants
    63
    59
    44
    No statistical analyses for this end point

    Secondary: Change in GA morphology from Baseline to Week 96 on multimodal imaging - Number of participants with increase in Fundus autofluorescence

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    End point title
    		 Change in GA morphology from Baseline to Week 96 on multimodal imaging - Number of participants with increase in Fundus autofluorescence
    End point description
    Change in retinal morphology on multimodal imaging.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 5, 12, 24, 36, 48, 72 and 96
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    75
    78
    74
    Units: Participants
        Week 5 (n=23,24,0)
    23
    23
    999
        Week 12 (n=75,73,74)
    74
    73
    73
        Week 24 (n=75,78,72)
    72
    78
    71
        Week 36 (n=70,70, 71)
    66
    69
    70
        Week 48 (n=67,72,68)
    67
    71
    68
        Week 72 (61, 62,59)
    60
    60
    56
        Week 96 (n=52,49, 34)
    50
    48
    33
    No statistical analyses for this end point

    Secondary: Change in Best corrected visual acuity (BCVA) Score from Baseline through Week 96 via the early treatment for diabetic retinopathy (ETDRS) chart

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    End point title
    		 Change in Best corrected visual acuity (BCVA) Score from Baseline through Week 96 via the early treatment for diabetic retinopathy (ETDRS) chart
    End point description
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 5, 8, 12, 24, 36, 48, 72 and 96
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    81
    79
    73
    Units: Letters read
    least squares mean (standard error)
        Week 1 (n=81,78,0)
    -2.0 ( 1.54 )
    -7.0 ( 1.56 )
    999 ( 999 )
        Week 5 (n=81,78,0)
    -0.8 ( 0.88 )
    -3.3 ( 0.89 )
    999 ( 999 )
        Week 8 (n=79,77,0)
    -0.1 ( 0.85 )
    -1.7 ( 0.86 )
    999 ( 999 )
        Week 12 (n=79,79,73)
    -1.1 ( 0.91 )
    -2.5 ( 0.91 )
    -0.7 ( 0.96 )
        Week 24 (n=78,78,71)
    -2.7 ( 1.03 )
    -6.3 ( 1.03 )
    -1.1 ( 1.09 )
        Week 36 (75,74,72)
    -2.5 ( 1.24 )
    -7.7 ( 1.25 )
    -3.0 ( 1.30 )
        Week 48 (n=73,75,69)
    -2.6 ( 1.48 )
    -7.3 ( 1.46 )
    -5.3 ( 1.54 )
        Week 72 (n=63, 70, 58)
    -4.1 ( 1.54 )
    -7.9 ( 1.50 )
    -8.8 ( 1.61 )
        Week 96 (n=54,51,35)
    -5.5 ( 1.78 )
    -10.0 ( 1.78 )
    -12.7 ( 2.02 )
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 12
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.32
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 12
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.33
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 24
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 36
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 3.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.81
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 24
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 -2.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.49
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 36
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -4.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 48
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 6.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.14
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 48
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.12
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 72
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    4.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 8.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.24
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 72
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 4.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.2
    Statistical analysis title
    		 GT005 Medium dose [5E10 vg] v Untreated control
    Statistical analysis description
    Week 96
    Comparison groups
    GT005 Medium dose [5E10 vg] v Untreated control
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    7.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 11.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.7
    Statistical analysis title
    		 GT005 High dose [2E11 vg] v Untreated control
    Statistical analysis description
    Week 96
    Comparison groups
    GT005 High dose [2E11 vg] v Untreated control
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 mixed model repeated measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 7.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.68

    Secondary: Change in Low luminance difference (LLD) letter count from Baseline at Weeks 12, 24, 36, 48, 72 and 96, via early treatment for diabetic retinopathy (ETDRS) chart

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    End point title
    		 Change in Low luminance difference (LLD) letter count from Baseline at Weeks 12, 24, 36, 48, 72 and 96, via early treatment for diabetic retinopathy (ETDRS) chart
    End point description
    LLD was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The test was to be performed after BCVA testing, prior to pupil dilation, and distance refraction was to be carried out before Low Luminance Visual Acuity (LLVA) was measured. LLVA was to be measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the subject read the normally illuminated ETDRS chart. The LLD was calculated as the difference between BCVA and LLVA. Initially, letters were to be read at a distance of 4 metres from the chart. If <20 letters were read at 4 metres, testing at 1 metre should have been performed. LLD was to be reported as number of letters read correctly by the subject. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 72 and 96
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    79
    76
    74
    Units: Letters read
    arithmetic mean (standard deviation)
        Week 12
    -0.6 ( 7.59 )
    -1.1 ( 9.63 )
    1.2 ( 9.51 )
        Week 24 (n=78,75,71)
    -0.6 ( 10.10 )
    -2.5 ( 12.73 )
    0.5 ( 12.01 )
        Week 36 (75,72,71)
    0.0 ( 9.90 )
    -2.6 ( 13.40 )
    -0.1 ( 11.12 )
        Week 48 (n=73,73,69)
    -0.5 ( 10.31 )
    -1.5 ( 15.18 )
    -0.4 ( 12.93 )
        Week 72 (n=63,67,58)
    -0.5 ( 13.15 )
    -5.2 ( 17.24 )
    -2.5 ( 14.93 )
        Week 96 (n=54,49,35)
    -3.1 ( 16.11 )
    -2.2 ( 13.48 )
    -5.9 ( 16.82 )
    No statistical analyses for this end point

    Secondary: Reading performance, measured as the MRS (words per minute), as assessed by Minnesota low-vision reading test (MNRead) chart: summary statistics for change from baseline by visit for the study eye

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    End point title
    		 Reading performance, measured as the MRS (words per minute), as assessed by Minnesota low-vision reading test (MNRead) chart: summary statistics for change from baseline by visit for the study eye
    End point description
    The maximum reading speed (MRS) represents the highest reading speed an individual can achieve when print size is not a limiting factor. Essentially, it measures how quickly a person can read text when the print is large enough to be easily readable. A higher count represents better visual functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 72 and 96
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    73
    72
    65
    Units: Words read per minute
    arithmetic mean (standard deviation)
        Week 24 (n=73,72,65)
    -15.756 ( 32.7268 )
    -12.368 ( 43.2054 )
    -15.769 ( 40.5051 )
        Week 36 (71,70,65)
    -18.488 ( 54.7913 )
    -15.673 ( 31.7802 )
    -3.689 ( 94.1057 )
        Week 48 (n=69,67,62)
    -20.734 ( 36.4110 )
    -6.678 ( 49.0844 )
    -17.297 ( 56.8547 )
        Week 72 (n=57,64,53)
    -24.485 ( 45.8525 )
    -20.798 ( 39.6796 )
    -26.121 ( 40.8016 )
        Week 96 (n=48,47,29)
    -24.678 ( 44.7777 )
    -25.178 ( 39.7216 )
    -19.242 ( 45.0703 )
    No statistical analyses for this end point

    Secondary: Change from Baseline at Weeks 24, 36, 48, 72 and 96 in Functional reading independence (FRI) index

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    End point title
    		 Change from Baseline at Weeks 24, 36, 48, 72 and 96 in Functional reading independence (FRI) index
    End point description
    The FRI index is a patient-reported outcome measure developed specifically for use in GA patients. The FRI index evaluates the level of independence subjects have in performing everyday activities that require reading, such as writing a cheque or reading a prescription. Scores derived from the index range from 1 (unable to do) to 4 (total independence). A higher score represents better visual functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 36, 48, 72 and 96
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    77
    75
    67
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 24 (n=77,75,67)
    -0.4 ( 5.20 )
    -1.4 ( 4.74 )
    -0.1 ( 3.98 )
        Week 36 (71,70,65)
    -0.8 ( 4.64 )
    -1.1 ( 4.31 )
    -0.1 ( 4.67 )
        Week 48 (n=70,73,65)
    -0.3 ( 4.76 )
    -1.4 ( 4.87 )
    -0.2 ( 4.50 )
        Week 72 (n=63,69,58)
    -0.8 ( 4.93 )
    -1.3 ( 5.19 )
    -1.5 ( 5.37 )
        Week 96 (n=54,51,32)
    -1.4 ( 5.57 )
    -1.4 ( 4.41 )
    -1.1 ( 5.11 )
    No statistical analyses for this end point

    Secondary: Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Composite Score

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    End point title
    		 Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Composite Score
    End point description
    The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 36, 48, 72 and 96
    End point values
    		 GT005 Medium dose [5E10 vg] GT005 High dose [2E11 vg] Untreated control
    Number of subjects analysed
    77
    78
    67
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 24 (n=77,78,67)
    -1.466 ( 12.8742 )
    -2.289 ( 12.3295 )
    -1.270 ( 11.2063 )
        Week 36 (71,73,65)
    -1.955 ( 11.5060 )
    -3.479 ( 12.0848 )
    -2.273 ( 12.2395 )
        Week 48 (n=70,74,65)
    -2.501 ( 12.9563 )
    -3.113 ( 11.9974 )
    -4.403 ( 14.2465 )
        Week 72 (n=63,69,54)
    -4.232 ( 14.6259 )
    -3.432 ( 11.3840 )
    -6.583 ( 15.5133 )
        Week 96 (n=54,51,33)
    -6.341 ( 14.4187 )
    -7.718 ( 10.9016 )
    -6.804 ( 15.4812 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    GT005@Medium dose@[5E10 vg]
    Reporting group description
    		 GT005@Medium dose@[5E10 vg]

    Reporting group title
    Overall
    Reporting group description
    		 Overall

    Reporting group title
    Untreated control
    Reporting group description
    		 Untreated control

    Reporting group title
    GT005@High dose@[2E11 vg]
    Reporting group description
    		 GT005@High dose@[2E11 vg]

    Serious adverse events
    		 GT005@Medium dose@[5E10 vg] Overall Untreated control GT005@High dose@[2E11 vg]
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 87 (25.29%)
    57 / 255 (22.35%)
    10 / 82 (12.20%)
    25 / 86 (29.07%)
         number of deaths (all causes)
    4
    6
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell myeloma
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcomatoid carcinoma of the lung
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pneumonitis aspiration
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Dural tear
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial rupture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open globe injury - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 87 (3.45%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Bundle branch block left
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Mitral valve incompetence
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vitreous haemorrhage - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endophthalmitis - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    3 / 86 (3.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pneumonia serratia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GT005@Medium dose@[5E10 vg] Overall Untreated control GT005@High dose@[2E11 vg]
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 87 (87.36%)
    201 / 255 (78.82%)
    50 / 82 (60.98%)
    75 / 86 (87.21%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Eye naevus - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    3 / 87 (3.45%)
    5 / 255 (1.96%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    4
    6
    1
    1
    Basal cell carcinoma - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Bladder cancer
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Thyroid cancer metastatic
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Prostate cancer
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Lipoma
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Keratoacanthoma
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Vascular disorders
    Lymphocele
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Orthostatic hypotension
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Aortic aneurysm
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Arteriosclerosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypertension
         subjects affected / exposed
    4 / 87 (4.60%)
    9 / 255 (3.53%)
    1 / 82 (1.22%)
    4 / 86 (4.65%)
         occurrences all number
    4
    9
    1
    4
    Hypertensive crisis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypertensive emergency
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    1
    3
    1
    1
    Subclavian artery stenosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Venous thrombosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    White coat hypertension
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    General disorders and administration site conditions
    Illness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Discomfort
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Facial pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Facial pain - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 87 (0.00%)
    4 / 255 (1.57%)
    1 / 82 (1.22%)
    3 / 86 (3.49%)
         occurrences all number
    0
    4
    1
    3
    Pyrexia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Prosthetic cardiac valve stenosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Infusion site bruising
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Social circumstances
    Edentulous
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Reproductive system and breast disorders
    Prostatomegaly
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Prostatitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 87 (1.15%)
    4 / 255 (1.57%)
    2 / 82 (2.44%)
    1 / 86 (1.16%)
         occurrences all number
    1
    4
    2
    1
    Cough
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    1
    3
    1
    1
    Catarrh
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pulmonary mass
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Paranasal sinus mucosal hypertrophy
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pulmonary oedema
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Mood altered
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Insomnia
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Hallucination
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Depression
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Charles Bonnet syndrome
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    1
    3
    1
    1
    Product issues
    Device dislocation - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cholelithiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Investigations
    Eosinophil count increased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    5 / 87 (5.75%)
    9 / 255 (3.53%)
    2 / 82 (2.44%)
    2 / 86 (2.33%)
         occurrences all number
    6
    10
    2
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 87 (2.30%)
    4 / 255 (1.57%)
    2 / 82 (2.44%)
    0 / 86 (0.00%)
         occurrences all number
    2
    4
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    3 / 87 (3.45%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    3 / 87 (3.45%)
    6 / 255 (2.35%)
    3 / 82 (3.66%)
    0 / 86 (0.00%)
         occurrences all number
    4
    7
    3
    0
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    0
    2
    Blood urea increased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Body temperature increased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Full blood count abnormal
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    0
    2
    Intraocular pressure increased - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Intraocular pressure increased - Study eye
         subjects affected / exposed
    11 / 87 (12.64%)
    13 / 255 (5.10%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    12
    14
    0
    2
    Lipase increased
         subjects affected / exposed
    2 / 87 (2.30%)
    6 / 255 (2.35%)
    0 / 82 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    2
    6
    0
    4
    Liver function test increased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Mean cell haemoglobin concentration decreased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Platelet count decreased
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Red blood cell count decreased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Accidental exposure to product - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Chemical burns of eye - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Chemical burns of eye - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Pelvic fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Craniofacial fracture - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Eye contusion - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eyelid contusion - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eyelid injury - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 87 (0.00%)
    5 / 255 (1.96%)
    2 / 82 (2.44%)
    3 / 86 (3.49%)
         occurrences all number
    0
    5
    2
    3
    Foot fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hand fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Humerus fracture
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyphaema - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    3
    0
    3
    Joint injury
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Patella fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Corneal abrasion - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Procedural nausea
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Vascular access site haematoma
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Product administered at inappropriate site - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Radius fracture
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Retinal tear - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Rib fracture
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin abrasion
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Skin laceration - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Spinal compression fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Splinter
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Stoma complication
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Suture related complication - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Tooth fracture
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Procedural pain - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Wound
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Congenital, familial and genetic disorders
    Corneal dystrophy - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Adenomatous polyposis coli
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Corneal dystrophy - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Aortic valve calcification
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Arrhythmia
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Atrial fibrillation
         subjects affected / exposed
    1 / 87 (1.15%)
    6 / 255 (2.35%)
    1 / 82 (1.22%)
    4 / 86 (4.65%)
         occurrences all number
    1
    6
    1
    4
    Cardiac amyloidosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Coronary artery disease
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Left ventricular failure
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences all number
    0
    3
    1
    2
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cerebral atrophy
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Amputation stump pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Balance disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Altered state of consciousness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Ageusia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Gerstmann's syndrome
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Encephalopathy
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Cognitive disorder
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Headache
         subjects affected / exposed
    1 / 87 (1.15%)
    6 / 255 (2.35%)
    0 / 82 (0.00%)
    5 / 86 (5.81%)
         occurrences all number
    1
    6
    0
    5
    Hypoaesthesia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ilioinguinal neuralgia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nerve compression
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Neuralgia - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Seizure
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Syncope
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Essential tremor
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Vertebral artery stenosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    VIth nerve paralysis - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 87 (3.45%)
    8 / 255 (3.14%)
    2 / 82 (2.44%)
    3 / 86 (3.49%)
         occurrences all number
    3
    8
    2
    3
    Leukocytosis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Blood loss anaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Splenomegaly
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Spontaneous haematoma
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ear and labyrinth disorders
    Meniere's disease
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Middle ear effusion
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Motion sickness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eye disorders
    Cataract nuclear - Study eye
         subjects affected / exposed
    3 / 87 (3.45%)
    6 / 255 (2.35%)
    0 / 82 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    3
    7
    0
    4
    Anterior capsule contraction - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Anterior capsule contraction - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Anterior chamber cell - Study eye
         subjects affected / exposed
    4 / 87 (4.60%)
    8 / 255 (3.14%)
    0 / 82 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    4
    8
    0
    4
    Anterior chamber flare - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Blepharitis - Fellow eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Blepharitis - Study eye
         subjects affected / exposed
    3 / 87 (3.45%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    3
    4
    0
    1
    Borderline glaucoma - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Borderline glaucoma - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cataract - Fellow eye
         subjects affected / exposed
    5 / 87 (5.75%)
    17 / 255 (6.67%)
    2 / 82 (2.44%)
    10 / 86 (11.63%)
         occurrences all number
    5
    17
    2
    10
    Cataract - Study eye
         subjects affected / exposed
    21 / 87 (24.14%)
    44 / 255 (17.25%)
    3 / 82 (3.66%)
    20 / 86 (23.26%)
         occurrences all number
    21
    44
    3
    20
    Cataract nuclear - Fellow eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Cataract subcapsular - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Cataract subcapsular - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    1
    3
    0
    2
    Chalazion - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Chalazion - Study eye
         subjects affected / exposed
    3 / 87 (3.45%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    3
    4
    0
    1
    Choroidal detachment - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Choroidal haemorrhage - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Corneal epithelial microcysts - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Choroidal neovascularisation - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    7 / 255 (2.75%)
    2 / 82 (2.44%)
    3 / 86 (3.49%)
         occurrences all number
    2
    8
    2
    4
    Chromatopsia - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Conjunctival haemorrhage - Study eye
         subjects affected / exposed
    18 / 87 (20.69%)
    31 / 255 (12.16%)
    1 / 82 (1.22%)
    12 / 86 (13.95%)
         occurrences all number
    21
    35
    1
    13
    Conjunctival oedema - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Corneal defect - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Corneal disorder - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Choroidal neovascularisation - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    1
    3
    1
    1
    Corneal erosion - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Corneal oedema - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Corneal oedema - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    1
    5
    0
    4
    Corneal striae - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cystoid macular oedema - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    1
    3
    0
    2
    Dermatochalasis - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ectropion - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Diplopia - Fellow eye
         subjects affected / exposed
    3 / 87 (3.45%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    3
    4
    0
    1
    Diplopia - Study eye
         subjects affected / exposed
    4 / 87 (4.60%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    4
    5
    0
    1
    Dry age-related macular degeneration - Fellow eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Dry eye - Fellow eye
         subjects affected / exposed
    2 / 87 (2.30%)
    7 / 255 (2.75%)
    1 / 82 (1.22%)
    4 / 86 (4.65%)
         occurrences all number
    2
    7
    1
    4
    Dry eye - Study eye
         subjects affected / exposed
    4 / 87 (4.60%)
    9 / 255 (3.53%)
    1 / 82 (1.22%)
    4 / 86 (4.65%)
         occurrences all number
    4
    9
    1
    4
    Ectropion - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences all number
    0
    3
    1
    2
    Detachment of retinal pigment epithelium - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eczema eyelids - Fellow eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Foreign body sensation in eyes - Study eye
         subjects affected / exposed
    3 / 87 (3.45%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    3
    5
    0
    2
    Epiretinal membrane - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Exophthalmos - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Eye discharge - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eye inflammation - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Eye irritation - Study eye
         subjects affected / exposed
    6 / 87 (6.90%)
    8 / 255 (3.14%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    6
    8
    0
    2
    Eye pain - Study eye
         subjects affected / exposed
    5 / 87 (5.75%)
    12 / 255 (4.71%)
    0 / 82 (0.00%)
    7 / 86 (8.14%)
         occurrences all number
    6
    13
    0
    7
    Eye pruritus - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    1
    5
    0
    4
    Eyelid bleeding - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    3
    0
    1
    Eyelid oedema - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eyelid pain - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eyelid ptosis - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eyelids pruritus - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Eyelids pruritus - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    3
    0
    1
    Eczema eyelids - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Foveal degeneration - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Lagophthalmos - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Fuchs' syndrome - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Glare - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Glaucoma - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    1
    3
    0
    2
    Glaucoma - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    4
    0
    2
    Hypotony of eye - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Iridocyclitis - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    1
    4
    0
    3
    Iritis - Study eye
         subjects affected / exposed
    4 / 87 (4.60%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    4
    5
    0
    1
    Keratic precipitates - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Keratitis - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Keratitis - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Lacrimation decreased - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Lacrimation decreased - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Lacrimation disorder - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    0
    2
    Lacrimation increased - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Fuchs' syndrome - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Ocular discomfort - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    4
    0
    2
    Optic ischaemic neuropathy - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Neovascular age-related macular degeneration - Fellow eye
         subjects affected / exposed
    2 / 87 (2.30%)
    5 / 255 (1.96%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences all number
    2
    5
    1
    2
    Metamorphopsia - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Metamorphopsia - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Macular oedema - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Macular hole - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Lenticular opacities - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Lens dislocation - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Ocular hyperaemia - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Ocular hypertension - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ocular hypertension - Study eye
         subjects affected / exposed
    6 / 87 (6.90%)
    12 / 255 (4.71%)
    0 / 82 (0.00%)
    6 / 86 (6.98%)
         occurrences all number
    6
    12
    0
    6
    Optic disc haemorrhage - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Optic ischaemic neuropathy - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ocular discomfort - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Punctate keratitis - Fellow eye
         subjects affected / exposed
    4 / 87 (4.60%)
    10 / 255 (3.92%)
    0 / 82 (0.00%)
    6 / 86 (6.98%)
         occurrences all number
    4
    10
    0
    6
    Pterygium - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Posterior capsule opacification - Study eye
         subjects affected / exposed
    3 / 87 (3.45%)
    9 / 255 (3.53%)
    2 / 82 (2.44%)
    4 / 86 (4.65%)
         occurrences all number
    3
    9
    2
    4
    Posterior capsule opacification - Fellow eye
         subjects affected / exposed
    5 / 87 (5.75%)
    11 / 255 (4.31%)
    2 / 82 (2.44%)
    4 / 86 (4.65%)
         occurrences all number
    5
    11
    2
    4
    Photopsia - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    5
    0
    3
    Photopsia - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Photophobia - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    0
    2
    Periorbital pain - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Optic nerve sheath haemorrhage - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Punctate keratitis - Study eye
         subjects affected / exposed
    6 / 87 (6.90%)
    12 / 255 (4.71%)
    0 / 82 (0.00%)
    6 / 86 (6.98%)
         occurrences all number
    6
    12
    0
    6
    Retinal oedema - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Retinal haemorrhage - Study eye
         subjects affected / exposed
    8 / 87 (9.20%)
    20 / 255 (7.84%)
    2 / 82 (2.44%)
    10 / 86 (11.63%)
         occurrences all number
    9
    21
    2
    10
    Retinal haemorrhage - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    1
    3
    0
    2
    Retinal detachment - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    1
    3
    0
    2
    Retinal depigmentation - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Retinal depigmentation - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Retinal cyst - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Retinal pigmentation - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Vitreoretinal traction syndrome - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Retinal tear - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Retinal tear - Study eye
         subjects affected / exposed
    5 / 87 (5.75%)
    11 / 255 (4.31%)
    0 / 82 (0.00%)
    6 / 86 (6.98%)
         occurrences all number
    5
    11
    0
    6
    Retinal vein occlusion - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Subretinal fluid - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Swelling of eyelid - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Tractional retinal detachment - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Trichiasis - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vitreal cells - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Visual impairment - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    2
    6
    0
    4
    Visual impairment - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    1
    3
    0
    2
    Visual field defect - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Vision blurred - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Ulcerative keratitis - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Trichiasis - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Retinal pigmentation - Study eye
         subjects affected / exposed
    12 / 87 (13.79%)
    34 / 255 (13.33%)
    0 / 82 (0.00%)
    22 / 86 (25.58%)
         occurrences all number
    13
    35
    0
    22
    Vitreous detachment - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    4 / 255 (1.57%)
    2 / 82 (2.44%)
    1 / 86 (1.16%)
         occurrences all number
    1
    4
    2
    1
    Vitreous floaters - Fellow eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vitreous floaters - Study eye
         subjects affected / exposed
    3 / 87 (3.45%)
    7 / 255 (2.75%)
    0 / 82 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    3
    8
    0
    5
    Vitreous haemorrhage - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Vitreous haemorrhage - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    8 / 255 (3.14%)
    0 / 82 (0.00%)
    6 / 86 (6.98%)
         occurrences all number
    2
    8
    0
    6
    Vitreous opacities - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    3
    4
    0
    1
    Gastrointestinal disorders
    Gastric ulcer
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences all number
    0
    3
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Constipation
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    1
    5
    0
    4
    Dental caries
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Diverticulum
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Duodenal ulcer
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Pancreatitis acute
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nausea
         subjects affected / exposed
    3 / 87 (3.45%)
    6 / 255 (2.35%)
    0 / 82 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    3
    7
    0
    4
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hiatus hernia
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Gastritis erosive
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Proctalgia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Toothache
         subjects affected / exposed
    1 / 87 (1.15%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    1
    4
    0
    3
    Vomiting
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    3
    0
    1
    Oesophageal dysplasia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Sebaceous gland disorder
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eczema
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Eczema asteatotic
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Lichenoid keratosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Rash
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Dermatitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Skin irritation
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Skin mass - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    0
    2
    Renal impairment
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    2 / 82 (2.44%)
    0 / 86 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Glomerulosclerosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Incontinence
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Microalbuminuria
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 255 (1.96%)
    2 / 82 (2.44%)
    2 / 86 (2.33%)
         occurrences all number
    1
    5
    2
    2
    Renal cyst
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Acute kidney injury
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    3
    0
    1
    Urinary tract obstruction
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Ureteric dilatation
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    1
    3
    1
    1
    Musculoskeletal and connective tissue disorders
    Greater trochanteric pain syndrome
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Arthritis
         subjects affected / exposed
    1 / 87 (1.15%)
    4 / 255 (1.57%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences all number
    1
    4
    1
    2
    Flank pain
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Bursitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Back pain
         subjects affected / exposed
    4 / 87 (4.60%)
    7 / 255 (2.75%)
    2 / 82 (2.44%)
    1 / 86 (1.16%)
         occurrences all number
    4
    7
    2
    1
    Foot deformity
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Arthralgia
         subjects affected / exposed
    2 / 87 (2.30%)
    7 / 255 (2.75%)
    2 / 82 (2.44%)
    3 / 86 (3.49%)
         occurrences all number
    2
    9
    3
    4
    Groin pain
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Muscle disorder
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Muscle tightness
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 255 (1.18%)
    3 / 82 (3.66%)
    0 / 86 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Osteoporosis
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 255 (1.18%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences all number
    0
    4
    2
    2
    Spinal stenosis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 255 (1.96%)
    2 / 82 (2.44%)
    2 / 86 (2.33%)
         occurrences all number
    1
    6
    3
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 87 (2.30%)
    5 / 255 (1.96%)
    2 / 82 (2.44%)
    1 / 86 (1.16%)
         occurrences all number
    2
    5
    2
    1
    Bacterial infection
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Appendicitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Abscess oral
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Abscess neck
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Abscess intestinal
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    COVID-19
         subjects affected / exposed
    14 / 87 (16.09%)
    35 / 255 (13.73%)
    9 / 82 (10.98%)
    12 / 86 (13.95%)
         occurrences all number
    14
    36
    10
    12
    Hordeolum - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Cellulitis
         subjects affected / exposed
    2 / 87 (2.30%)
    4 / 255 (1.57%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    4
    0
    2
    Conjunctivitis - Fellow eye
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Conjunctivitis - Study eye
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    3
    0
    1
    Conjunctivitis bacterial - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Cystitis
         subjects affected / exposed
    3 / 87 (3.45%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    6
    6
    0
    0
    Diverticulitis
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    2
    3
    1
    0
    Eye infection - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Eye infection - Study eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gingivitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gingival abscess
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eyelid infection - Fellow eye
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Candida infection
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hordeolum - Study eye
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Influenza
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Intervertebral discitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Kidney infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Leprosy
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Lyme disease
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 255 (1.96%)
    0 / 82 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    3
    7
    0
    4
    Oral candidiasis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Otitis media acute
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Periodontitis
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 87 (1.15%)
    6 / 255 (2.35%)
    0 / 82 (0.00%)
    5 / 86 (5.81%)
         occurrences all number
    1
    6
    0
    5
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Pyelonephritis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pyuria
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Root canal infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 87 (1.15%)
    6 / 255 (2.35%)
    1 / 82 (1.22%)
    4 / 86 (4.65%)
         occurrences all number
    2
    8
    1
    5
    Skin bacterial infection
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Skin infection
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Tinea pedis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 87 (0.00%)
    4 / 255 (1.57%)
    1 / 82 (1.22%)
    3 / 86 (3.49%)
         occurrences all number
    0
    4
    1
    3
    Tooth infection
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 255 (1.18%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    3
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    2 / 82 (2.44%)
    0 / 86 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Urinary tract infection
         subjects affected / exposed
    7 / 87 (8.05%)
    13 / 255 (5.10%)
    3 / 82 (3.66%)
    3 / 86 (3.49%)
         occurrences all number
    7
    13
    3
    3
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Metabolism and nutrition disorders
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 255 (1.18%)
    2 / 82 (2.44%)
    0 / 86 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    4 / 255 (1.57%)
    1 / 82 (1.22%)
    2 / 86 (2.33%)
         occurrences all number
    1
    4
    1
    2
    Hypoglycaemia
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    0 / 86 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Obesity
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 255 (0.39%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    0
    1
    Iron deficiency
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 255 (0.78%)
    1 / 82 (1.22%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    1
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    2
    0
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 255 (0.78%)
    0 / 82 (0.00%)
    0 / 86 (0.00%)
         occurrences all number
    2
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2020
    This protocol amendment included: study period extended to 2 years with the addition of Weeks 72 and 96. Revision of objectives to include the additional Week 72 and 96 timepoints, the addition of secondary objective: The change from baseline to Week 72 and Week 96 in geographic atrophy (GA) area as measured by fundus autofluorescence (FAF). Additional optical coherence tomography-angiography (OCT-A); OCT-A additional imaging assessments for CNV conversion. Genotyping ICF included as a separate statement. Protocol amendments classified as administrational changes, substantial amendments, and urgent amendments.
    03 Jun 2021
    Corrected the imaging modality for retinal anatomical measures. Clarification of OCT-A certification. Microperimetry imaging assessment requirements.
    04 Jan 2022
    This protocol amendment included randomisation of study eye, clarification of bleb number, GT005 deferral guidance, additional safety assessment with FAF at Week 5, and vital signs.
    15 Sep 2022
    This protocol amendment included: updated primary endpoint read-out timepoint from Week 48 to Week 72, several secondary endpoints have been changed to exploratory endpoints, updates to secondary and exploratory endpoints to be reported ‘through Week 96, updates to the statistical methods, study rationale, and dose rationale. Updated safety assessment guidance under Section 7.4.2.1 and updated the list of Adverse Events of Special Interest (AESI) to include RPE changes, updated recent information under ‘Risks associated with GT005. Updated guidance on the timing of cataract surgery during the study under Section 1.6.1.2, Risks Associated with the surgical and study procedures. Updates to Section 3.1 Study Overview, Section 3.4.1 Masking, and Section 5.5 Measures to Minimize Bias.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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