Study of Efficacy and Safety of Brolucizumab Versus Panre... | NCT04278417

NCT04278417

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brolucizumab 6 mg	Experimental	Intra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90	Biological: Brolucizumab 6 mg
Panretinal photocoagulation laser Arm	Active Comparator	Initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed	Procedure: Panretinal photocoagulation laser

Name	Type	Description	Arm Group Labels	Other Names
Brolucizumab 6 mg	Biological	3 x q6w loading injections, followed by q12w maintenance through Week 90	Brolucizumab 6 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye	BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.	Baseline, Week 54

Secondary Outcomes

Measure	Description	Time Frame
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye	Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) < 7.

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Retina Associates SW		Tucson	Arizona	85704	United States
Retina- Vitreous Assoc Medical Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42024409	Derived	Wolf S, Chen Y, Li X, Shimura M, Sakamoto T, Wykoff CC, Emanuelli A, Salehi-Had H, Yan K, Kovacic L, Kim Y. Brolucizumab in the Treatment of Proliferative Diabetic Retinopathy: The CONDOR Randomized Clinical Trial. JAMA Ophthalmol. 2026 Jun 1;144(6):500-507. doi: 10.1001/jamaophthalmol.2026.1008.

Label	URL
A Plain Language Trial Summary is available on www.novctrd.com	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 28, 2021	Jun 24, 2024

Arm/Group Information

ID	Title	Description
BG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
BG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
BG002	Total	Total of all reporting groups

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
	BG00053.2± 11.88 BG00154.7± 10.83 BG00253.9± 11.39

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000144 BG001132 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0013 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 in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Posted

Least Squares Mean

Standard Error

Letters Read

Baseline, Week 54

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Units	Counts
Participants	OG000342 OG001337

Title

Denominators

Categories

Title	Measurements
	OG0000.2± 0.72 OG001-4.2± 0.73

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	1	ANCOVA		<0.001		LS mean difference	4.4	Standard Error of the Mean	1.03	2-Sided	95	2.4	6.4					Non-Inferiority	Non-inferiority of brolucizumab to PRP with respect to change from baseline in BCVA at Week 54, considering a non-inferiority margin of 4 ETDRS letters. Assuming that the BCVA changes follow a normal distribution with equal means between treatments, and a common standard deviation of 10 letters, for a one-sided alpha level of 0.025, with 300 subjects per arm there is >99% power to reject the null hypothesis that brolucizumab 6 mg is inferior to PRP.

Secondary

Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye

Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) < 7.

Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Week 54

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye

Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye

Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

PRP = Panretinal photocoagulation laser

Full Analysis Set (FAS), for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Up to Week 54

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Units	Counts
Participants

Secondary

Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye

Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

PRP = Panretinal photocoagulation laser

Full Analysis Set (FAS), for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Up to Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Units	Counts
Participants

Secondary

Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye

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 functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

The AUC in change from Baseline in BCVA up to Week 54 (or Week 96) is referred to as the averaged change from Baseline in BCVA at each visit up to 54 (or Week 96), which was calculated as (BCVA at Week 6 + BCVA at Week 12 + ... + BCVA at Week 54 (or Week 96)) / number of visits with valid BCVA data from Week 6 to Week 54 (or Week 96) - BCVA at Baseline.

Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Posted

Least Squares Mean

95% Confidence Interval

Letters read

Baseline, up to Week 54 and up to Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.

Secondary

Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment".

A lower score represents better functioning.

Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Baseline, Week 54 and Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

A lower score represents better functioning.

Full Analysis Set- Observed, for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Baseline, Week 54 and Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

A lower score represents better functioning.

Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Baseline, Week 54 and Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

A lower score represents better functioning.

Full Analysis Set-Observed, for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

Baseline, Week 54 and Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54 and up to Week 96

The vision-threatening complications associated with Diabetic retinopathy (DR) are defined as any event of the following list occurring in the study eye at any time point after Baseline:

Center-involved Diabetic macular edema (CI-DME) as defined as Central sub-field thickness (CSFT) ≥280 µm according to Central reading center (CRC) evaluation of Optical coherent tomography (OCT) image
Retinal detachment
Vitreous hemorrhage
Neovascular glaucoma, iris/ anterior chamber angle neovascularization
Vitrectomy for DR complications

Full Analysis Set - Observed, for patients with a valid measurement with no protocol deviations with impact.

Posted

Count of Participants

Participants

up to Week 54 and up to Week 96

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Ocular AEs (>= 2% in Any Treatment Arm) by 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.

AEs that started after alternative diabetic retinopathy treatment/relevant diabetic macular edema treatment in the study eye are censored.

Safety Set

Posted

Count of Participants

Participants

Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Secondary

Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term

AEs that started after alternative diabetic retinopathy treatment/relevant diabetic macular edema treatment in the study eye are censored.

Safety Set

Posted

Count of Participants

Participants

Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.

ID	Title	Description
OG000	Brolucizumab 6 mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.
OG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.

Post-Hoc

All Collected Deaths

On-treatment deaths are reported from first dose of study treatment until end of study treatment at the time of the interim analysis, plus 4 weeks post treatment, up to a maximum timeframe of approximately 96 weeks. Post-treatment deaths are reported for the timeframe of greater than 30 days after last treatment, also up to Week 96. All deaths refer to the sum of on-treatment and post-treatment deaths.

Not Posted

Aug 9999

On-treatment - within 30 days after last treatment, up to Week 96; Post-treatment - greater than 30 days after last treatment, also up to Week 96.

Participants

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	Brolucizumab 6mg	Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	8	347	96	347	241	347
EG001	Panretinal Photocoagulation Laser Arm	Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.	9	342	105	342	254	342
EG002	Overall	Overall	17	689	201	689	495	689

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Acute cardiac event	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0014 affected342 at risk EG0024 affected689 at risk
Angina unstable	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0012 affected342 at risk EG0022 affected689 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Atrial flutter	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Cardiac arrest	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Cardiac failure	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0011 affected342 at risk EG0023 affected689 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Cardiomegaly	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Coronary artery disease	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected347 at risk EG0012 affected342 at risk EG0025 affected689 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Myocardial infarction	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0014 affected342 at risk EG0025 affected689 at risk
Myocarditis	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Palpitations	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Pericarditis	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Endocrine pancreatic disorder	Endocrine disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Cataract - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0011 affected342 at risk EG0023 affected689 at risk
Cataract - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0014 affected342 at risk EG0025 affected689 at risk
Cataract cortical - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Diabetic retinopathy - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0011 affected342 at risk EG0023 affected689 at risk
Diabetic retinopathy - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0012 affected342 at risk EG0022 affected689 at risk
Epiretinal membrane - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Glaucoma - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Glaucoma - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0013 affected342 at risk EG0023 affected689 at risk
Macular hole - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Macular oedema - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Macular oedema - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0012 affected342 at risk EG0022 affected689 at risk
Pupillary block - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Retinal artery occlusion - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Retinal detachment - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Retinal detachment - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Retinal haemorrhage - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Retinal haemorrhage - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Retinal neovascularisation - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Retinal occlusive vasculitis - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Retinal vasculitis - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Retinopathy proliferative - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Strabismus - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Tractional retinal detachment - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Tractional retinal detachment - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0013 affected342 at risk EG0025 affected689 at risk
Uveitis - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected347 at risk EG0010 affected342 at risk EG0023 affected689 at risk
Vitreous haemorrhage - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00014 affected347 at risk EG0019 affected342 at risk EG00223 affected689 at risk
Vitreous haemorrhage - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0004 affected347 at risk EG00119 affected342 at risk EG00223 affected689 at risk
Ascites	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Constipation	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Gastric stenosis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Gastritis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Nausea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Chest pain	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Death	General disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Generalised oedema	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Hernia pain	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Oedema	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Pyrexia	General disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Abscess limb	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Arthritis bacterial	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Bacteraemia	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
COVID-19	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Cellulitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0012 affected342 at risk EG0024 affected689 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Endophthalmitis - Study eye	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Erysipelas	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Escherichia infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Gangrene	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Localised infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Mastitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Measles	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Osteomyelitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0011 affected342 at risk EG0023 affected689 at risk
Otitis media chronic	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0012 affected342 at risk EG0022 affected689 at risk
Pitted keratolysis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Pneumonia	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0004 affected347 at risk EG0011 affected342 at risk EG0025 affected689 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0012 affected342 at risk EG0022 affected689 at risk
Postoperative wound infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Sepsis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Urinary tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Wound infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0012 affected342 at risk EG0023 affected689 at risk
Hyphaema - Study eye	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Periprocedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Blood glucose increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Blood potassium increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Blood pressure abnormal	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Blood triglycerides increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Intraocular pressure increased - Study eye	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0012 affected342 at risk EG0022 affected689 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0011 affected342 at risk EG0022 affected689 at risk
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk
Gastric cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Cerebellar infarction	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Cerebral infarction	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0005 affected347 at risk EG0011 affected342 at risk EG0026 affected689 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0012 affected342 at risk EG0024 affected689 at risk
Coma	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0012 affected342 at risk EG0022 affected689 at risk
Dystonia	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Headache	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected347 at risk EG0012 affected342 at risk EG0025 affected689 at risk
Loss of consciousness	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Syncope	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0014 affected342 at risk EG0025 affected689 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0013 affected342 at risk EG0024 affected689 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0011 affected342 at risk EG0023 affected689 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Proteinuria	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Renal failure	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected347 at risk EG0011 affected342 at risk EG0024 affected689 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Ovarian cyst torsion	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected347 at risk EG0010 affected342 at risk EG0021 affected689 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0014 affected342 at risk EG0024 affected689 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Hypertension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0005 affected347 at risk EG0011 affected342 at risk EG0026 affected689 at risk
Hypertensive crisis	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected347 at risk EG0011 affected342 at risk EG0021 affected689 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected347 at risk EG0010 affected342 at risk EG0022 affected689 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG00015 affected347 at risk EG00116 affected342 at risk EG00231 affected689 at risk
Cataract - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00022 affected347 at risk EG00128 affected342 at risk EG00250 affected689 at risk
Cataract - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00026 affected347 at risk EG00129 affected342 at risk EG00255 affected689 at risk
Conjunctival haemorrhage - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00010 affected347 at risk EG0017 affected342 at risk EG00217 affected689 at risk
Diabetic retinal oedema - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00020 affected347 at risk EG00118 affected342 at risk EG00238 affected689 at risk
Diabetic retinal oedema - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0008 affected347 at risk EG00141 affected342 at risk EG00249 affected689 at risk
Diabetic retinopathy - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00014 affected347 at risk EG00115 affected342 at risk EG00229 affected689 at risk
Diabetic retinopathy - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0004 affected347 at risk EG00115 affected342 at risk EG00219 affected689 at risk
Dry eye - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00014 affected347 at risk EG0019 affected342 at risk EG00223 affected689 at risk
Dry eye - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00015 affected347 at risk EG00111 affected342 at risk EG00226 affected689 at risk
Epiretinal membrane - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0007 affected347 at risk EG0013 affected342 at risk EG00210 affected689 at risk
Eye pain - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected347 at risk EG0017 affected342 at risk EG00210 affected689 at risk
Macular oedema - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0009 affected347 at risk EG00112 affected342 at risk EG00221 affected689 at risk
Macular oedema - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0009 affected347 at risk EG00134 affected342 at risk EG00243 affected689 at risk
Retinal haemorrhage - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0005 affected347 at risk EG00111 affected342 at risk EG00216 affected689 at risk
Tractional retinal detachment - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0004 affected347 at risk EG0017 affected342 at risk EG00211 affected689 at risk
Visual acuity reduced - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0007 affected347 at risk EG0014 affected342 at risk EG00211 affected689 at risk
Vitreous detachment - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0006 affected347 at risk EG0017 affected342 at risk EG00213 affected689 at risk
Vitreous floaters - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0009 affected347 at risk EG0019 affected342 at risk EG00218 affected689 at risk
Vitreous haemorrhage - Fellow eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00035 affected347 at risk EG00148 affected342 at risk EG00283 affected689 at risk
Vitreous haemorrhage - Study eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG00040 affected347 at risk EG00178 affected342 at risk EG002118 affected689 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0007 affected347 at risk EG0016 affected342 at risk EG00213 affected689 at risk
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0004 affected347 at risk EG0019 affected342 at risk EG00213 affected689 at risk
Pyrexia	General disorders	MedDRA (27.0)	Systematic Assessment	EG00016 affected347 at risk EG0017 affected342 at risk EG00223 affected689 at risk
Bronchitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0004 affected347 at risk EG0017 affected342 at risk EG00211 affected689 at risk
COVID-19	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG00044 affected347 at risk EG00153 affected342 at risk EG00297 affected689 at risk
Conjunctivitis - Fellow eye	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0008 affected347 at risk EG0015 affected342 at risk EG00213 affected689 at risk
Conjunctivitis - Study eye	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0007 affected347 at risk EG0014 affected342 at risk EG00211 affected689 at risk
Influenza	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0005 affected347 at risk EG0018 affected342 at risk EG00213 affected689 at risk
Nasopharyngitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG00022 affected347 at risk EG00117 affected342 at risk EG00239 affected689 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG00030 affected347 at risk EG00118 affected342 at risk EG00248 affected689 at risk
Urinary tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG00011 affected347 at risk EG00113 affected342 at risk EG00224 affected689 at risk
Intraocular pressure increased - Fellow eye	Investigations	MedDRA (27.0)	Systematic Assessment	EG00010 affected347 at risk EG0013 affected342 at risk EG00213 affected689 at risk
Intraocular pressure increased - Study eye	Investigations	MedDRA (27.0)	Systematic Assessment	EG00011 affected347 at risk EG0015 affected342 at risk EG00216 affected689 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0009 affected347 at risk EG0015 affected342 at risk EG00214 affected689 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0007 affected347 at risk EG0017 affected342 at risk EG00214 affected689 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00011 affected347 at risk EG00110 affected342 at risk EG00221 affected689 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00011 affected347 at risk EG0013 affected342 at risk EG00214 affected689 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00010 affected347 at risk EG00110 affected342 at risk EG00220 affected689 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG00011 affected347 at risk EG0015 affected342 at risk EG00216 affected689 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0007 affected347 at risk EG0017 affected342 at risk EG00214 affected689 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0005 affected347 at risk EG0017 affected342 at risk EG00212 affected689 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected347 at risk EG0019 affected342 at risk EG00212 affected689 at risk
Depression	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0008 affected347 at risk EG0013 affected342 at risk EG00211 affected689 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0007 affected347 at risk EG0014 affected342 at risk EG00211 affected689 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG00015 affected347 at risk EG00112 affected342 at risk EG00227 affected689 at risk
Hypertension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG00031 affected347 at risk EG00129 affected342 at risk EG00260 affected689 at risk

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms