FOCUS: A Phase I/II First in Human Study to Evaluate the... | NCT03846193 | Trialant
NCT03846193
Sponsor
Gyroscope Therapeutics Limited
Status
Terminated
Last Update Posted
Jan 28, 2026Actual
Enrollment
56Actual
Phase
Phase 1Phase 2
Conditions
Dry Age-related Macular Degeneration
Macular Degeneration
Retinal Disease
Eye Diseases
Retinal Degeneration
Geographic Atrophy
Macular Atrophy
Interventions
GT005
GT005 / Device: Orbit™ Subretinal Delivery System
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03846193
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GT005-01
Secondary IDs
ID
Type
Description
Link
CPPY988A12101
Other Identifier
Novartis
Brief Title
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
Official Title
FOCUS: An Open Label First in Human Phase I/II Multicentre Study to Evaluate the Safety, Dose Response and Efficacy of GT005 Administered as a Single Subretinal Injection in Subjects With Macular Atrophy Due to AMD
Acronym
Not provided
Organization
Gyroscope Therapeutics LimitedINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.
Expanded Access Info
No
Start Date
Dec 17, 2018Actual
Primary Completion Date
Jun 25, 2024Actual
Completion Date
Jun 25, 2024Actual
First Submitted Date
Feb 13, 2019
First Submission Date that Met QC Criteria
Feb 15, 2019
First Posted Date
Feb 19, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Mar 7, 2025
Results First Submitted that Met QC Criteria
Aug 7, 2025
Results First Posted Date
Aug 24, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 8, 2026
Last Update Posted Date
Jan 28, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gyroscope Therapeutics LimitedINDUSTRY
Collaborators
Name
Class
Novartis Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Yes
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to Age-related macular degeneration (AMD).
Detailed Description
This was an open label first-in-human Phase I/II multicenter study to evaluate the safety, dose response and efficacy of GT005 in participants with Geographic atrophy (GA) due to Age-related macular degeneration (AMD).
The study treatment GT005 consists of an Adeno-associated virus serotype 2 (AAV2) expressing human complement factor I (hCFI). The treatment was administered as a single subretinal administration in one eye - the "study eye". Both eyes were assessed at the screening visit. If both eyes meet the eligibility criteria, the study eye will be the worse seeing eye, or the eye with the largest geographic atrophy (GA) lesion area for eyes with equivalent visual acuity, unless the participant (in consultation with the surgeon) expresses an alternative preference.
The study was conducted in 4 parts: in Part 1 and Part 2 GT005 was administered subretinally via transvitreal procedure; in Part 3 and 4 GT005 was delivered subretinally via a suprachoroidal cannulation with the Orbit Subretinal delivery system (SDS). The Orbit SDS is a 510(k) cleared device in the US, whereby Parts 3 and 4 were only conducted at US sites. The treatment consisted in 3 dose levels: low dose, 2E10 vector genomes (vg); medium dose, 5E10 vg; and high dose, 2E11 vg.
The study consisted of up to 13 visits over a 5-year period. All participants were assessed for the occurrence of treatment emergent adverse events (AE)s at each visit and underwent visual function and retinal imaging assessments and biological sampling as per the schedule of assessments.
This study was conducted in compliance with Independent ethics committees (IECs) / Institutional review boards (IRBs), informed consent regulations, the Declaration of Helsinki, nternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and the Food and Drug Administration (FDA) guidance.
Conditions Module
Conditions
Dry Age-related Macular Degeneration
Macular Degeneration
Retinal Disease
Eye Diseases
Retinal Degeneration
Geographic Atrophy
Macular Atrophy
Keywords
Dry Age-related Macular Degeneration (Dry AMD)
AMD
Atrophic AMD
Geographic Atrophy (GA)
Dry-AMD
Dry AMD
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
56Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
GT005 2E10 vg via Transvitreal Procedure
Experimental
GT005 2E10 vg via Transvitreal Procedure
Biological: GT005
GT005 5E10 vg via Transvitreal Procedure
Experimental
GT005 5E10 vg via Transvitreal Procedure
Biological: GT005
GT005 2E11 vg via Transvitreal Procedure
Experimental
GT005 2E11 vg via Transvitreal Procedure
Biological: GT005
GT005 5E10 vg with Orbit Subretinal Delivery System
Experimental
GT005 5E10 vg with Orbit Subretinal Delivery System
Device: GT005 / Device: Orbit™ Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
Experimental
GT005 2E11 vg with Orbit Subretinal Delivery System
Device: GT005 / Device: Orbit™ Subretinal Delivery System
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GT005
Biological
GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI). GT005 was administered as a single time subretinal injection into the study eye of subjects allocated to one of the two GT005 doses.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
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.
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Summary of Non-Ocular Treatment Emergent Adverse Events
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.
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred
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.
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Secondary Outcomes
Measure
Description
Time Frame
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Best corrected visual acuity (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.
Up to Week 240
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Able and willing to give consent to study participation
Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye (except if the subject is monocular)
Cohorts 1 to 6: GA lesion(s) total size in the study eye must be ≥1.25mm2 and ≤17.5mm2.
Cohort 7: GA lesion(s) total size in the study eye must be ≥1.25mm2
GA lesion(s) in the study eye must reside completely within the FAF fundus image
Cohorts 1 to 3: BCVA of ≤50 letters (6/36 Snellen acuity equivalent or worse) using ETDRS charts in the study eye Cohorts 4 to 7: BCVA of ≥24 letters (6/95 and 20/320 Snellen acuity equivalent or better) using ETDRS charts in the study eye
Aged ≥55 years
Able to attend all study visits and complete the study procedures
Women of child-bearing potential need to have a negative urine pregnancy test within two weeks prior to receiving the drug. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilised (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy)
Exclusion Criteria:
Have evidence or history of Choroidal Neovascularisation (CNV) in the study eye. Subjects are permitted to have CNV in the fellow eye defined as either:
Non-exudative/sub-clinical fellow eye CNV identified at screening, or
Known history of fellow eye CNV with either ≥2 years since diagnosis or with no active treatment required in 6 months prior to screening
Presence of moderate/severe non-proliferative diabetic retinopathy or worse in the study eye
Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminum garnet capsulotomy is permitted if performed >10 weeks prior to Visit 1
Have clinically significant cataract that may require surgery during the study period in the study eye
Presence of moderate to severe glaucomatous optic neuropathy in the study eye; uncontrolled IOP despite the use of more than two topical agents; a history of glaucoma-filtering or valve surgery is also excluded
Axial myopia of greater than -8 diopters in the study eye
Have received any investigational product for the treatment of GA within the past 6 months or 5 half-lives (whichever is longer), other than nutritional supplements such as the Age-Related Eye Disease Study (AREDS) formula
Have received a gene or cell therapy at any time
Have a contraindication to the specified protocol corticosteroid regimen
Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
Active malignancy within the past 12 months, except for: Appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) ≥12 months
Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study
Cohorts 5 to 7 only: presence of metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, and other implanted electrodes or stimulators
Dreismann AK, McClements ME, Barnard AR, Orhan E, Hughes JP, Lachmann PJ, MacLaren RE. Functional expression of complement factor I following AAV-mediated gene delivery in the retina of mice and human cells. Gene Ther. 2021 May;28(5):265-276. doi: 10.1038/s41434-021-00239-9. Epub 2021 Mar 10.
See Also Links
Label
URL
A Plain Language Trial Summary is available on www.novctrd.com
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.)
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
FG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 15, 2022
Mar 7, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
A dose escalation study of the safety and efficacy of a single subretinal injection of GT005 in subjects with Macular Atrophy due to AMD
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
GT005 2E10 vg via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
GT005 / Device: Orbit™ Subretinal Delivery System
Device
GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI).
A single dose of GT005 was administered with subretinal injection via suprachoroidal cannulation approach.
Device: Orbit™ Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Low-Luminance Deficit best corrected visual acuity (BCVA-LLVA) 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.
Up to Week 240
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Macular sensitivity as assessed by mesopic Microperimetry.
Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 63 Area.
Up to Week 240
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Macular sensitivity as assessed by mesopic Microperimetry.
Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 95 Area.
Up to Week 240
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Macular sensitivity as assessed by mesopic Microperimetry
Up to Week 240
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Macular sensitivity as assessed by mesopic Microperimetry
Up to Week 240
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Macular sensitivity as assessed by mesopic Microperimetry
Up to Week 240
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Change from baseline in GA size as assessed by fundus autofluorescence
Up to Week 240
Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.
The rate of successful delivery of GT005 is the number of full doses delivered divided by number of Orbit devices used.
This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of GT005 administered was consistent across all arms and cohorts.
The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.
Day 1
Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.
The rate of successful delivery of BSS was the number of full doses delivered divided by number of Orbit devices used.
This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of BSS administered was consistent across all arms and cohorts.
The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.
Day 1
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
Day 1
Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
Day 1
Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
Day 1
Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
FG004
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
FG0006 subjects
FG00110 subjects
FG00215 subjects
FG0035 subjects
FG00422 subjects
Initially Randomized to Receive PPY988 With the Transvitreal Procedure
FG0004 subjects
FG00110 subjects
FG00215 subjects
FG0030 subjects
FG0040 subjects
Received PPY988 With the Transvitreal Procedure, After the Orbit-SDS Was Attempted Unsuccessfully
Received PPY988 with the Transvitreal Procedure, after the Orbit Subretinal Delivery System was attempted unsuccessfully (regardless if completed or disc early)
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Initially Randomized to Receive PPY988 With the Orbit Subretinal Delivery System
Initially randomized to receive PPY988 with the Orbit Subretinal Delivery System (regardless if successful or unsuccessful)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG00422 subjects
Initially Randomized to Receive PPY988 With the Orbit Subretinal Delivery System
Initially randomized to receive PPY988 with the Orbit Subretinal Delivery System but the delivery was unsuccessful
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
Received PPY988 With the Transvitreal Procedure
FG0006 subjects
FG00110 subjects
FG00215 subjects
FG0030 subjects
FG0040 subjects
Received PPY988 With the Orbit Subretinal Delivery System
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG00422 subjects
COMPLETED
FG0006 subjects
FG00110 subjects
FG00214 subjects
FG0033 subjects
FG00421 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
switched to the GT005 2E10 vg via Transvitreal Procedure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
BG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
BG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
BG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
BG004
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG00110
BG00215
BG0033
BG00422
BG00556
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00081.7± 8.21
BG00179.0± 5.12
BG00280.5± 4.02
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
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.
Safety Analysis Set - All treated patients
Posted
Count of Participants
Participants
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
OG004
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
Units
Counts
Participants
OG0006
OG00110
OG00215
OG003
Title
Denominators
Categories
Subjects with at least one TEAE
Title
Measurements
OG0003
OG0017
OG00214
OG003
Primary
Summary of Non-Ocular Treatment Emergent Adverse Events
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.
Safety Analysis Set - All treated patients
Posted
Count of Participants
Participants
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
Primary
Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred
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.
Safety Analysis Set - All treated patients
Posted
Count of Participants
Participants
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
Secondary
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Best corrected visual acuity (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.
Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
ETDRS letters read
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
Secondary
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Low-Luminance Deficit best corrected visual acuity (BCVA-LLVA) 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.
Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
ETDRS letters read
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Macular sensitivity as assessed by mesopic Microperimetry.
Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 63 Area.
Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
degrees squared (deg2)
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Macular sensitivity as assessed by mesopic Microperimetry.
Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 95 Area.
Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
degrees squared (deg2)
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Macular sensitivity as assessed by mesopic Microperimetry
Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
Decibel (dB)
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
OG004
GT005 2E11 vg With Orbit Subretinal Delivery System
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Macular sensitivity as assessed by mesopic Microperimetry
Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
MP Number of Scotomatous Points
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
OG004
GT005 2E11 vg With Orbit Subretinal Delivery System
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Macular sensitivity as assessed by mesopic Microperimetry
Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
MP Percent Fixation Loss (%)
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
OG004
GT005 2E11 vg With Orbit Subretinal Delivery System
Secondary
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Change from baseline in GA size as assessed by fundus autofluorescence
Full Analysis Set - for patients with a valid measurement without a protocol deviation with impact
Posted
Mean
Standard Deviation
mm
Up to Week 240
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
OG004
GT005 2E11 vg With Orbit Subretinal Delivery System
Secondary
Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.
The rate of successful delivery of GT005 is the number of full doses delivered divided by number of Orbit devices used.
This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of GT005 administered was consistent across all arms and cohorts.
The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.
All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted.
34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted.
The arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.
Posted
Number
percent of devices
Day 1
Orbit devices
Orbit devices
ID
Title
Description
OG000
Total US Patients
Secondary
Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US.
The rate of successful delivery of BSS was the number of full doses delivered divided by number of Orbit devices used.
This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of BSS administered was consistent across all arms and cohorts.
The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.
All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted.
34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted.
The arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.
Posted
Number
percent of devices
Day 1
Orbit devices
Orbit devices
ID
Title
Description
OG000
Total US Patients
Secondary
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
Safety Analysis Set - All treated patients
Posted
Count of Participants
Participants
Day 1
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
Secondary
Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
Safety Analysis Set - All treated patients
Posted
Count of Participants
Participants
Day 1
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
OG003
Secondary
Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
Safety Analysis Set - All treated patients
Posted
Count of Participants
Participants
Day 1
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
Secondary
Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS.
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.
Safety Analysis Set - All treated patients
Posted
Count of Participants
Participants
Day 1
ID
Title
Description
OG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
OG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
OG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
Time Frame
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
1
6
2
6
4
6
EG001
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
3
10
6
10
10
10
EG002
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
0
15
4
15
15
15
EG003
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
0
3
0
3
3
3
EG004
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
0
22
5
22
22
22
EG005
Overall
Overall
4
56
17
56
54
56
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG0030 affected3 at risk
EG0040 affected22 at risk
EG0051 affected56 at risk
Atrial fibrillation
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Septic shock
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected15 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Lymphatic system neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neovascular age-related macular degeneration - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Ocular discomfort - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Ocular hypertension - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Ocular hypertension - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Optic disc haemorrhage - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Optic disc haemorrhage - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Periorbital oedema - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Posterior capsule opacification - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Posterior capsule opacification - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Retinal aneurysm rupture - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Retinal depigmentation - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Retinal haemorrhage - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Retinal haemorrhage - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0021 affected15 at risk
EG003
Retinal pigmentation - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Retinal pigmentation - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0014 affected10 at risk
EG00210 affected15 at risk
EG003
Retinal tear - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Vision blurred - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Vision blurred - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Visual acuity reduced - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected10 at risk
EG0020 affected15 at risk
EG003
Visual acuity reduced - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Visual field defect - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0022 affected15 at risk
EG003
Visual field defect - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0023 affected15 at risk
EG003
Visual impairment - Fellow eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Visual impairment - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Vitreous floaters - Study eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected10 at risk
EG0021 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected15 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Intestinal polyp
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Oesophageal perforation
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Chest pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Hernia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Polyp
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0022 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Conjunctivitis - Fellow eye
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Conjunctivitis - Study eye
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Conjunctivitis bacterial - Fellow eye
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Conjunctivitis bacterial - Study eye
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Conjunctivitis viral - Fellow eye
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected15 at risk
EG003
Conjunctivitis viral - Study eye
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected15 at risk
EG003
Cystitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Ear infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Fungal infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Hordeolum - Fellow eye
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected10 at risk
EG0021 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0022 affected15 at risk
EG003
Viral sinusitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected10 at risk
EG0020 affected15 at risk
EG003
Corneal abrasion - Study eye
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Eye contusion - Fellow eye
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected10 at risk
EG0022 affected15 at risk
EG003
Foreign body in eye - Fellow eye
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Post procedural discomfort - Study eye
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Procedural pain - Study eye
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0023 affected15 at risk
EG003
Scrotal haematoma
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Suture related complication - Study eye
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Blood folate decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Blood glucose increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Blood potassium increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Blood pressure increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Coronavirus test positive
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Heart rate irregular
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Intraocular pressure increased - Fellow eye
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Intraocular pressure increased - Study eye
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Lipids increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Liver function test increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Protein C increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Protein total decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
White blood cell count increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Adenoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Sweat gland tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Cerebral artery thrombosis
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Cluster headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Dementia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Meralgia paraesthetica
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Ophthalmic migraine - Fellow eye
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Ophthalmic migraine - Study eye
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Vertebral artery occlusion
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0023 affected15 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected10 at risk
EG0020 affected15 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Haemosiderin stain
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Precancerous skin lesion
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Stasis dermatitis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected10 at risk
EG0021 affected15 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Hypotension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0020 affected15 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected10 at risk
EG0021 affected15 at risk
EG003
Poor peripheral circulation
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Vein disorder
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Venous hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected10 at risk
EG0020 affected15 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.