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    Clinical Trial Results:
    A Multicenter, Patient-Masked, Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System

    Summary
    EudraCT number
    2010-019079-32
    Trial protocol
    PT   DE   GB   CZ   IT  
    Global end of trial date
    05 Feb 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Jan 2017
    First version publication date
    07 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    190342-033D
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01080209
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, United Kingdom, SL7 1YL
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    Scientific contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.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
    30 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the biodegradation and related safety profile of the intravitreal Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS®) implant matrix
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Feb 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 142
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    India: 2
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Philippines: 10
    Country: Number of subjects enrolled
    Portugal: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Worldwide total number of subjects
    215
    EEA total number of subjects
    47
    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)
    71
    From 65 to 84 years
    121
    85 years and over
    23

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients enrolled in this extension study from the following parent studies: 190342-027D, 190342-028D, 190342-030D, 190342-031D, 190342-032D, and 190342-036. No treatment was administered in this study, so the treatment groups reflect the treatments received in the parent studies.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Brimo PS DDS® 400 μg (2 implants)
    Arm description
    Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
    Arm type
    Experimental

    Investigational medicinal product name
    Brimo PS DDS®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.

    Arm title
    Brimo PS DDS® 400 μg (1 implant)
    Arm description
    Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
    Arm type
    Experimental

    Investigational medicinal product name
    Brimo PS DDS®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.

    Arm title
    Brimo PS DDS® 200 μg (2 implants)
    Arm description
    Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
    Arm type
    Experimental

    Investigational medicinal product name
    Brimo PS DDS®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.

    Arm title
    Brimo PS DDS® 200 μg (1 implant)
    Arm description
    Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
    Arm type
    Experimental

    Investigational medicinal product name
    Brimo PS DDS®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.

    Arm title
    Brimo PS DDS® 100 μg (1 implant)
    Arm description
    Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
    Arm type
    Experimental

    Investigational medicinal product name
    Brimo PS DDS®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.

    Arm title
    Brimo PS DDS® 50 μg (1 implant)
    Arm description
    Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
    Arm type
    Experimental

    Investigational medicinal product name
    Brimo PS DDS®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.

    Arm title
    Sham
    Arm description
    Patients who received sham in a previous study.
    Arm type
    Sham Procedure

    Investigational medicinal product name
    Sham
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients who received sham in a previous study.

    Number of subjects in period 1
    Brimo PS DDS® 400 μg (2 implants) Brimo PS DDS® 400 μg (1 implant) Brimo PS DDS® 200 μg (2 implants) Brimo PS DDS® 200 μg (1 implant) Brimo PS DDS® 100 μg (1 implant) Brimo PS DDS® 50 μg (1 implant) Sham
    Started
    28
    53
    33
    42
    6
    2
    51
    Completed
    22
    42
    28
    37
    6
    2
    44
    Not completed
    6
    11
    5
    5
    0
    0
    7
         Adverse event, serious fatal
    4
    1
    1
    -
    -
    -
    2
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    2
         Personal Reasons
    2
    5
    4
    -
    -
    -
    1
         Principal Investigator Left Site
    -
    4
    -
    5
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brimo PS DDS® 400 μg (2 implants)
    Reporting group description
    Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.

    Reporting group title
    Brimo PS DDS® 400 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 200 μg (2 implants)
    Reporting group description
    Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.

    Reporting group title
    Brimo PS DDS® 200 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 100 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 50 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.

    Reporting group title
    Sham
    Reporting group description
    Patients who received sham in a previous study.

    Reporting group values
    Brimo PS DDS® 400 μg (2 implants) Brimo PS DDS® 400 μg (1 implant) Brimo PS DDS® 200 μg (2 implants) Brimo PS DDS® 200 μg (1 implant) Brimo PS DDS® 100 μg (1 implant) Brimo PS DDS® 50 μg (1 implant) Sham Total
    Number of subjects
    28 53 33 42 6 2 51 215
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    2 23 3 20 3 0 20 71
        From 65-84 years
    19 29 24 19 3 1 26 121
        85 years and over
    7 1 6 3 0 1 5 23
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    77.7 ± 8.75 63 ± 15.32 78 ± 8.47 63.3 ± 15.05 60.8 ± 11.91 78 ± 9.9 68.2 ± 14.17 -
    Gender, Male/Female
    Units: Participants
        Female
    19 24 17 20 3 2 21 106
        Male
    9 29 16 22 3 0 30 109

    End points

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    End points reporting groups
    Reporting group title
    Brimo PS DDS® 400 μg (2 implants)
    Reporting group description
    Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.

    Reporting group title
    Brimo PS DDS® 400 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 200 μg (2 implants)
    Reporting group description
    Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.

    Reporting group title
    Brimo PS DDS® 200 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 100 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 50 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.

    Reporting group title
    Sham
    Reporting group description
    Patients who received sham in a previous study.

    Primary: Number of Patients with No Visible Implants in the Study Eye

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    End point title
    Number of Patients with No Visible Implants in the Study Eye [1]
    End point description
    Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
    End point type
    Primary
    End point timeframe
    Month 36
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistical analyses for this end point.
    End point values
    Brimo PS DDS® 400 μg (2 implants) Brimo PS DDS® 400 μg (1 implant) Brimo PS DDS® 200 μg (2 implants) Brimo PS DDS® 200 μg (1 implant) Brimo PS DDS® 100 μg (1 implant) Brimo PS DDS® 50 μg (1 implant) Sham
    Number of subjects analysed
    23
    42
    30
    37
    6
    2
    46
    Units: Patients
    14
    37
    26
    35
    6
    2
    46
    No statistical analyses for this end point

    Secondary: Number of Patients with Vision Loss in the Study Eye

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    End point title
    Number of Patients with Vision Loss in the Study Eye
    End point description
    Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline of Parent Study, Month 36
    End point values
    Brimo PS DDS® 400 μg (2 implants) Brimo PS DDS® 400 μg (1 implant) Brimo PS DDS® 200 μg (2 implants) Brimo PS DDS® 200 μg (1 implant) Brimo PS DDS® 100 μg (1 implant) Brimo PS DDS® 50 μg (1 implant) Sham
    Number of subjects analysed
    23
    42
    30
    37
    6
    2
    46
    Units: Patients
        Severe Vision Loss
    3
    1
    1
    0
    0
    0
    4
        Moderate Vision Loss
    6
    0
    6
    1
    0
    0
    6
        No or Mild Vision Loss
    14
    41
    23
    36
    6
    2
    36
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored from informed consent signature to the end of study for each subject.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Brimo PS DDS® 400 μg (2 implants)
    Reporting group description
    Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.

    Reporting group title
    Brimo PS DDS® 400 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 200 μg (2 implants)
    Reporting group description
    Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.

    Reporting group title
    Brimo PS DDS® 200 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 100 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.

    Reporting group title
    Brimo PS DDS® 50 μg (1 implant)
    Reporting group description
    Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.

    Reporting group title
    Sham
    Reporting group description
    Patients who received sham in a previous study.

    Serious adverse events
    Brimo PS DDS® 400 μg (2 implants) Brimo PS DDS® 400 μg (1 implant) Brimo PS DDS® 200 μg (2 implants) Brimo PS DDS® 200 μg (1 implant) Brimo PS DDS® 100 μg (1 implant) Brimo PS DDS® 50 μg (1 implant) Sham
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 28 (28.57%)
    11 / 53 (20.75%)
    7 / 33 (21.21%)
    7 / 42 (16.67%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    16 / 51 (31.37%)
         number of deaths (all causes)
    4
    1
    1
    0
    0
    0
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder Cancer
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Cancer Metastatic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's Lymphoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular Carcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer
    Additional description: Males Only
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer Recurrent
    Additional description: Males Only
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer Metastatic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal Cancer
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Oesophageal Carcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral Artery Stenosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intermittent Claudication
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden Cardiac Death
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cystocele
    Additional description: Females Only
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
    Additional description: Females Only
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
    Additional description: Males Only
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea Exertional
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Toxicity to Various Agents
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    2 / 33 (6.06%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory Arrest
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic Stroke
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Age-Related Macular Degeneration
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual Acuity Reduced
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal Vein Occlusion
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anterior Chamber Inflammation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open Angle Glaucoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic Atrophy
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocele
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis Ulcerative
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    1 / 42 (2.38%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium Difficile Colitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    1 / 33 (3.03%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 53 (1.89%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Brimo PS DDS® 400 μg (2 implants) Brimo PS DDS® 400 μg (1 implant) Brimo PS DDS® 200 μg (2 implants) Brimo PS DDS® 200 μg (1 implant) Brimo PS DDS® 100 μg (1 implant) Brimo PS DDS® 50 μg (1 implant) Sham
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 28 (64.29%)
    40 / 53 (75.47%)
    26 / 33 (78.79%)
    35 / 42 (83.33%)
    4 / 6 (66.67%)
    2 / 2 (100.00%)
    41 / 51 (80.39%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 53 (5.66%)
    3 / 33 (9.09%)
    4 / 42 (9.52%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    3
    3
    4
    0
    0
    4
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
    Additional description: Males Only
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    3 / 42 (7.14%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    3 / 42 (7.14%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    Investigations
    Intraocular Pressure Increased
         subjects affected / exposed
    0 / 28 (0.00%)
    6 / 53 (11.32%)
    0 / 33 (0.00%)
    4 / 42 (9.52%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    8
    0
    7
    0
    0
    8
    Cardiac disorders
    Coronary Artery Disease
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Neuropathy Peripheral
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    3 / 33 (9.09%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    3
    0
    0
    0
    0
    Dementia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Restless Legs Syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    3
    Ear and labyrinth disorders
    Ear Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    3 / 28 (10.71%)
    6 / 53 (11.32%)
    0 / 33 (0.00%)
    6 / 42 (14.29%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    6 / 51 (11.76%)
         occurrences all number
    4
    9
    0
    8
    0
    0
    11
    Visual Acuity Reduced
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 28 (10.71%)
    3 / 53 (5.66%)
    3 / 33 (9.09%)
    5 / 42 (11.90%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    3
    4
    6
    8
    0
    0
    0
    Age-Related Macular Degeneration
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    3 / 33 (9.09%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    4
    0
    0
    0
    0
    Vitreous Detachment
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    2 / 33 (6.06%)
    4 / 42 (9.52%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    4
    0
    2
    4
    0
    0
    6
    Vitreous Floaters
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    5 / 53 (9.43%)
    3 / 33 (9.09%)
    3 / 42 (7.14%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    7
    4
    3
    0
    0
    0
    Retinal Haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    2 / 33 (6.06%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    Posterior Capsule Opacification
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    4
    Dry Eye
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    5 / 53 (9.43%)
    2 / 33 (6.06%)
    4 / 42 (9.52%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    9
    4
    6
    0
    0
    0
    Macular Fibrosis
         subjects affected / exposed
    0 / 28 (0.00%)
    4 / 53 (7.55%)
    0 / 33 (0.00%)
    3 / 42 (7.14%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    4
    0
    4
    0
    0
    0
    Optic Disc Haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 53 (5.66%)
    2 / 33 (6.06%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    0
    0
    Glaucoma
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 53 (5.66%)
    0 / 33 (0.00%)
    4 / 42 (9.52%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    5 / 51 (9.80%)
         occurrences all number
    0
    3
    0
    4
    0
    0
    7
    Macular Degeneration
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 53 (5.66%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    0
    Blepharitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    2 / 33 (6.06%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    0
    Glare
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Cataract Cortical
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    3 / 42 (7.14%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    0
    0
    Cataract Subscapular
         subjects affected / exposed
    0 / 28 (0.00%)
    4 / 53 (7.55%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Dysphagia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    2 / 33 (6.06%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    0
    Gastrooesophageal Reflux Disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Dental Caries
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Stress Urinary Incontinence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    Back Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 53 (5.66%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 53 (5.66%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Otitis Media Chronic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    1 / 6 (16.67%)
    2 / 2 (100.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    Gout
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    2 / 33 (6.06%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 53 (0.00%)
    0 / 33 (0.00%)
    0 / 42 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jul 2010
    1) Ensure the study design could accommodate inclusion of patients from planned and future clinical studies with Brimonidine Tartrate PS DDS; 2) Update the method of IOP measurement to one considered more suitable for assessing safety in ocular posterior segment diseases; 3) Clarify that any abortion (spontaneous or nonspontaneous) is a serious adverse event; 4) The planned number of patients was changed from 290 to approximately 300.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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