Safety and Efficacy of AGN208397 in the Treatment of Macu... | NCT01027650 | Trialant
NCT01027650
Sponsor
Allergan
Status
Completed
Last Update Posted
Apr 29, 2014Estimated
Enrollment
121Actual
Phase
Phase 1Phase 2
Conditions
Macular Edema
Retinal Vein Occlusion
Interventions
AGN208397 intravitreal injection
dexamethasone intravitreal implant
Countries
United States
Australia
Canada
Israel
South Africa
Protocol Section
Identification Module
NCT ID
NCT01027650
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
208397-001
Secondary IDs
Not provided
Brief Title
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
Official Title
Not provided
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Mar 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2010
Primary Completion Date
Apr 2012Actual
Completion Date
Feb 2013Actual
First Submitted Date
Dec 4, 2009
First Submission Date that Met QC Criteria
Dec 4, 2009
First Posted Date
Dec 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 27, 2014
Results First Submitted that Met QC Criteria
Mar 27, 2014
Results First Posted Date
Apr 29, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 19, 2013
Certification/Extension First Submitted that Passed QC Review
Apr 19, 2013
Certification/Extension First Posted Date
Apr 29, 2013Estimated
Last Update Submitted Date
Mar 27, 2014
Last Update Posted Date
Apr 29, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.
Detailed Description
Not provided
Conditions Module
Conditions
Macular Edema
Retinal Vein Occlusion
Keywords
Not provided
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
121Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1 Cohort 1
Experimental
AGN208397 intravitreal injection 75 ug on Day 1.
Drug: AGN208397 intravitreal injection
Stage 1 Cohort 2
Experimental
AGN208397 intravitreal injection 300 ug on Day 1.
Drug: AGN208397 intravitreal injection
Stage 1 Cohort 3
Experimental
AGN208397 intravitreal injection 600 ug on Day 1.
Drug: AGN208397 intravitreal injection
Stage 1 Cohort 4
Experimental
AGN208397 intravitreal injection 900 ug on Day 1.
Drug: AGN208397 intravitreal injection
Stage 2 Arm 1
Experimental
AGN208397 intravitreal injection 600 ug on Day 1.
Drug: AGN208397 intravitreal injection
Stage 2 Arm 2
Experimental
AGN208397 intravitreal injection 450 ug on Day 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AGN208397 intravitreal injection
Drug
AGN208397 intravitreal injection on Day 1.
Stage 1 Cohort 1
Stage 1 Cohort 2
Stage 1 Cohort 3
Stage 1 Cohort 4
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Baseline, Month 1
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Baseline, Month 1
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
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). An increase in the number of letters read correctly means that vision has improved.
Baseline, Month 1
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
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). An increase in the number of letters read correctly means that vision has improved.
Baseline, Month 1
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Baseline, Month 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
macular edema due to retinal vein occlusion
visual acuity in the study eye between 20/320 to 20/40
Exclusion Criteria:
cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
use of injectable drugs in the study eye within 2 months prior to day 1
active eye infection in either eye
visual acuity in the non-study eye of 20/200 or worse
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Allergan
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Phoenix
Arizona
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Doses for Stage 2 were selected based on the safety and pharmacodynamic results from Stage 1. No patients in Stage 1 were enrolled in Stage 2.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
FG001
Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
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
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Singapore
Switzerland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantOutcomes Assessor
Drug: AGN208397 intravitreal injection
Stage 2 Arm 3
Experimental
AGN208397 intravitreal injection 300 ug on Day 1.
Drug: AGN208397 intravitreal injection
Stage 2 Arm 4
Active Comparator
Dexamethasone 700 ug intravitreal implant on Day 1.
Drug: dexamethasone intravitreal implant
Stage 2 Arm 1
Stage 2 Arm 2
Stage 2 Arm 3
dexamethasone intravitreal implant
Drug
Dexamethasone 700 ug intravitreal implant on Day 1.
Stage 2 Arm 4
Ozurdex®
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
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). An increase in the number of letters read correctly means that vision has improved.
Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
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). An increase in the number of letters read correctly means that vision has improved.
Baseline, Month 12
East Melbourne
Victoria
Australia
London
Ontario
Canada
Tel Aviv
Israel
Cape Town
South Africa
FG002
Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
FG003
Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
FG004
Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
FG005
Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
FG006
Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
FG007
Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG00425 subjects
FG00526 subjects
FG00625 subjects
FG00724 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG00423 subjects
FG00524 subjects
FG00624 subjects
FG00724 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
Type
Comment
Reasons
Personal Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
BG001
Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
BG002
Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
BG003
Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
BG004
Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
BG005
Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
BG006
Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
BG007
Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0026
BG0033
BG00425
BG00526
BG00625
BG00724
BG008121
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
<45 years
Title
Measurements
BG0001
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
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
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Safety Population: all patients who received study treatment
Posted
Mean
Standard Deviation
Microns
Baseline, Month 1
ID
Title
Description
OG000
Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
OG001
Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
OG002
Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000500.2± 197.58
OG001495.8± 163.13
OG002499.5± 158.33
OG003
Primary
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
Posted
Mean
Standard Deviation
Microns
Baseline, Month 1
ID
Title
Description
OG000
Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
OG001
Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
OG002
Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
Primary
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
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). An increase in the number of letters read correctly means that vision has improved.
Safety Population: all patients who received study treatment
Posted
Mean
Standard Deviation
Number of Letters Read Correctly
Baseline, Month 1
ID
Title
Description
OG000
Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
OG001
Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
OG002
Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
Primary
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
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). An increase in the number of letters read correctly means that vision has improved.
Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
Posted
Mean
Standard Deviation
Number of Letters Read Correctly
Baseline, Month 1
ID
Title
Description
OG000
Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
OG001
Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
OG002
Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
Secondary
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Safety Population: all patients who received study treatment
Posted
Mean
Standard Deviation
Microns
Baseline, Month 12
ID
Title
Description
OG000
Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
OG001
Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
OG002
Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
Secondary
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
Posted
Mean
Standard Deviation
Microns
Baseline, Month 12
ID
Title
Description
OG000
Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
OG001
Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
OG002
Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
Secondary
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
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). An increase in the number of letters read correctly means that vision has improved.
Safety Population: all patients who received study treatment
Posted
Mean
Standard Deviation
Number of Letters Read Correctly
Baseline, Month 12
ID
Title
Description
OG000
Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
OG001
Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
OG002
Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
Secondary
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
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). An increase in the number of letters read correctly means that vision has improved.
Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
Posted
Mean
Standard Deviation
Number of Letters Read Correctly
Baseline, Month 12
ID
Title
Description
OG000
Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
OG001
Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
OG002
Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
OG003
Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
Time Frame
Not provided
Description
Adverse events (AEs) and serious adverse events (SAEs) are reported by treatment group assigned during Stage 1 and Stage 2. The Safety Population consisted of all patients who received the study treatment, and was used to assess AEs and SAEs.
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
Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
1
6
6
6
EG001
Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
0
6
6
6
EG002
Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
1
6
6
6
EG003
Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
0
3
3
3
EG004
Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
4
25
25
25
EG005
Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
4
26
26
26
EG006
Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
2
25
25
25
EG007
Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
3
24
24
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG004
Cardiac Failure Congestive
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Facet Joint Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pseudoendophthalmitis
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Atrioventricular Block Second Degree
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Chest Pain
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vasculitis
Vascular disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Intraocular Pressure Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0004 affected6 at risk
EG0013 affected6 at risk
EG0021 affected6 at risk
EG0030 affected3 at risk
EG0046 affected25 at risk
EG0058 affected26 at risk
EG0069 affected25 at risk
EG0075 affected24 at risk
Conjunctival Haemorrhage
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected6 at risk
EG0022 affected6 at risk
EG003
Cataract
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0021 affected6 at risk
EG003
Retinal Haemorrhage
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0024 affected6 at risk
EG003
Blood Urea Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Protein Urine Present
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Eye Pain
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Macular Fibrosis
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Ocular Hypertension
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Cystoid Macular Oedema
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0023 affected6 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Medication Residue
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Vitreous Floaters
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Arteriosclerotic Retinopathy
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Eye Swelling
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Mean Cell Haemoglobin Concentration Decreased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Upper Respiratory Tract Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Upper Respiratory Tract Infection Bacterial
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal Pruritus
Reproductive system and breast disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0013 affected6 at risk
EG0021 affected6 at risk
EG003
Vitreous Detachment
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected6 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected6 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected6 at risk
EG003
Cataract subcapsular
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Foreign Body Sensation in Eyes
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Macular Oedema
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Photophobia
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
White Blood Cells Urine Positive
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Conjunctival Hyperaemia
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Conjunctival Oedema
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Eye Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Facial Pain
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Glaucoma
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Iris Adhesions
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Iris Neovascularisation
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Malaise
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Optic Nerve Infarction
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Posterior Capsule Opacification
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Retinal Aneurysm
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Retinal Neovascularisation
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Vitreous Opacities
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Weight Increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Vision Blurred
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected6 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Blood Triglycerides Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Diabetic Retinopathy
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Dry Eye
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Macular Cyst
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Macular Degeneration
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Nitrite Urine Present
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Retinal Exudates
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Urine Leukocyte Esterase Positive
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blepharal Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cataract Nuclear
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Localised Infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pterygium
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Retinal pigment epitheliopathy
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Retinal Vein Occlusion
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Optic Disc Haemorrhage
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Anterior Chamber Cell
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Anterior Chamber Angle Neovascularisation
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Anterior Chamber Flare
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Anterior Chamber Inflammation
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Lenticular Opacities
Eye disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 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
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.