OPT-302 With Aflibercept in Neovascular Age-related Macul... | NCT04757636

Label	Type	Description	Intervention Names
2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302	Experimental	2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.	Biological: 2.0 mg OPT-302 Biological: 2.0 aflibercept
2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302	Experimental	2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.	Biological: 2.0 mg OPT-302 Biological: 2.0 aflibercept
2.0 mg aflibercept with sham	Sham Comparator	2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.	Biological: 2.0 aflibercept Procedure: Sham

Name	Type	Description	Arm Group Labels	Other Names
2.0 mg OPT-302	Biological	intravitreal injection	2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302

Measure	Description	Time Frame
Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters	To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)	Baseline to Week 52

Measure	Description	Time Frame
Proportion of Participants Gaining 15 or More ETDRS BCVA Letters	To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.

Facility	Status	City	State	ZIP	Country	Contacts
COAST Investigational Site		Phoenix	Arizona	85053	United States
COAST Investigational Site

ID	Title	Description
FG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 19, 2023	Jul 17, 2025

Type

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Description

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Anticipated Posting Date

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Analyses

Primary

Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters

To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)

Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses.

Posted

Least Squares Mean

Standard Error

Letters read

Baseline to Week 52

ID	Title	Description
OG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection
OG001	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection Sham: intravitreal injection
OG002	2.0 mg Aflibercept With Sham	2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not. 2.0 aflibercept: intravitreal injection Sham: intravitreal injection

Units	Counts
Participants	OG000333 OG001330 OG002330

Title

Denominators

Categories

Title	Measurements
	OG00013.48± 0.729 OG00112.82± 0.728 OG00213.66± 0.728

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 OG002		MMRM		0.861409		Least Squares Mean Difference	-0.18	Standard Error of the Mean	1.030	2-Sided	95	-2.20	1.84					Superiority
OG001 OG002		MMRM		0.416264

Secondary

Proportion of Participants Gaining 15 or More ETDRS BCVA Letters

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.

Posted

Count of Participants

Participants

Baseline to Week 52

ID	Title	Description
OG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection
OG001	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered into the study eye alone at the alternating visits when aflibercept and OPT-302 were not administered. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection Sham: intravitreal injection

Secondary

Proportion of Participants Gaining 10 or More ETDRS BCVA Letters

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.

Posted

Count of Participants

Participants

Baseline to Week 52

ID	Title	Description
OG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection
OG001	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered into the study eye alone at the alternating visits when aflibercept and OPT-302 were not administered. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection Sham: intravitreal injection

Secondary

Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52. The secondary analysis presented used mixed model for repeated measures in the overall population.

Posted

Least Squares Mean

Standard Error

mm^2

Baseline to Week 52

ID	Title	Description
OG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection
OG001	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection Sham: intravitreal injection

Secondary

Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.

Posted

Count of Participants

Participants

at Week 52

ID	Title	Description
OG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection
OG001	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study at the alternating visits when aflibercept and OPT-302 were not administered. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection Sham: intravitreal injection

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Visual acuity reduced	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0011 events1 affected330 at risk EG0021 events1 affected330 at risk
Cataract	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0012 events2 affected330 at risk EG0020 events0 affected330 at risk
Cataract nuclear	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Cataract subcapsular	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Lenticular opacities	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Retinal detachment	Eye disorders	MedDRA 27.0	Systematic Assessment	Includes 1 non-study eye event in the Control arm	EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Retinal haemorrhage	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0012 events2 affected330 at risk EG0022 events2 affected330 at risk
Eye inflammation	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Uveitis	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Ocular hypertension	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA 27.0	Systematic Assessment	Includes 1 non-study eye event in the Extended Dosing arm and 1 non-study eye event in the Control arm	EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0022 events2 affected330 at risk
Endophthalmitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0003 events3 affected333 at risk EG0010 events0 affected330 at risk EG0022 events2 affected330 at risk
Cataract traumatic	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0004 events4 affected333 at risk EG0011 events1 affected330 at risk EG0021 events1 affected330 at risk
Cardiac failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0003 events3 affected333 at risk EG0012 events2 affected330 at risk EG0022 events2 affected330 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0014 events4 affected330 at risk EG0024 events4 affected330 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0011 events1 affected330 at risk EG0022 events2 affected330 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0011 events1 affected330 at risk EG0021 events1 affected330 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Atrial flutter	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0012 events2 affected330 at risk EG0021 events1 affected330 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0003 events1 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Angina unstable	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Left ventricular failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Degenerative multivalvular disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0022 events1 affected330 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0012 events1 affected330 at risk EG0020 events0 affected330 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0021 events1 affected330 at risk
Ascites	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Enteritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Gait disturbance	General disorders	MedDRA 27.0	Systematic Assessment		EG0002 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Ulcer haemorrhage	General disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Death	General disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0012 events2 affected330 at risk EG0020 events0 affected330 at risk
General physical health deterioration	General disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Malaise	General disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0023 events3 affected330 at risk
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0009 events7 affected333 at risk EG0014 events4 affected330 at risk EG0027 events7 affected330 at risk
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0003 events3 affected333 at risk EG0012 events2 affected330 at risk EG0021 events1 affected330 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0003 events3 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Appendicitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Bacteriuria	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Diverticulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Kidney infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Septic shock	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Sinusitis fungal	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0012 events1 affected330 at risk EG0021 events1 affected330 at risk
Complicated appendicitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Herpes zoster	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Peritonitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Urosepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Viral infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Appendicitis perforated	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Cystitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Focal peritonitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Herpes simplex hepatitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Liver abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Pneumonia viral	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Pyelonephritis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0023 events2 affected330 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0011 events1 affected330 at risk EG0021 events1 affected330 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0022 events2 affected330 at risk
Aortic injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Troponin increased	Investigations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0012 events2 affected330 at risk EG0020 events0 affected330 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Invasive breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0012 events2 affected330 at risk EG0020 events0 affected330 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Sarcoma uterus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Spindle cell sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0022 events1 affected330 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0012 events2 affected330 at risk EG0022 events2 affected330 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0012 events1 affected330 at risk EG0020 events0 affected330 at risk
Encephalitis autoimmune	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Essential tremor	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Syncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Transient ischaemic attach	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0022 events2 affected330 at risk
Cerebral infarction	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Dementia	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Polyneuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Presyncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Vertebrobasilar stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Alcoholism	Psychiatric disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Mental status changes	Psychiatric disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Urinary retention	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0011 events1 affected330 at risk EG0022 events1 affected330 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected333 at risk EG0010 events0 affected330 at risk EG0022 events2 affected330 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0021 events1 affected330 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0020 events0 affected330 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Varicose vein	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected333 at risk EG0010 events0 affected330 at risk EG0020 events0 affected330 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0011 events1 affected330 at risk EG0021 events1 affected330 at risk
Aortic dissection	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Hypertensive emergency	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected333 at risk EG0010 events0 affected330 at risk EG0021 events1 affected330 at risk

ID	Term
D057135	Wet Macular Degeneration
D008268	Macular Degeneration
D005128	Eye Diseases
D012164	Retinal Diseases
D012162	Retinal Degeneration

ID	Title	Description
BG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection
BG001	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection Sham: intravitreal injection
BG002	2.0 mg Aflibercept With Sham	2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not. 2.0 aflibercept: intravitreal injection Sham: intravitreal injection
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with OPT-302 administered alone at visits when aflibercept was not. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection	9	333	71	333	288	333
EG001	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg aflibercept intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered. 2.0 mg OPT-302: intravitreal injection 2.0 aflibercept: intravitreal injection Sham: intravitreal injection	12	330	61	330	290	330
EG002	2.0 mg Aflibercept With Sham	2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not. 2.0 aflibercept: intravitreal injection Sham: intravitreal injection	6	330	68	330	282	330