An Extension Study to Evaluate the Long-Term Safety of La... | NCT01602120

ID	Type	Description	Link
2012-000578-41	EudraCT Number

Status 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
CFD4870g Sham	Experimental	Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), will receive lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study up to approximately 96 months.	Drug: Lampalizumab
CFD4870g Lampalizumab	Experimental	Participants will receive lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study up to approximately 96 months.	Drug: Lampalizumab
GX29455 Sham	Experimental	Participants who were administered sham comparator in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months.	Drug: Lampalizumab
GX29455 Lampalizumab	Experimental	Participants who were administered lampalizumab in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months.	Drug: Lampalizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lampalizumab	Drug	Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.	CFD4870g Lampalizumab CFD4870g Sham GX29455 Lampalizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.	From Day 1 up to the last study visit (up to approximately 62 months)

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Retina Centers P.C.		Tucson	Arizona	85704	United States
Retina-Vitreous Assoc Med Grp

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CFD4870g Sham	Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.

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_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 18, 2017

Arm/Group Information

ID	Title	Description
BG000	CFD4870g Sham	Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.
BG001	CFD4870g Lampalizumab	Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.
BG002	GX29455 Sham	Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
BG003	GX29455 Lampalizumab	Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
BG004	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
	BG00079.4± 6.6 BG00179.4± 6.8 BG00276.7± 6.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG00133 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)

An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.

Safety population included all participants who were enrolled and received at least one lampalizumab injection in the extension study.

Posted

Number

percentage of participants

From Day 1 up to the last study visit (up to approximately 62 months)

ID	Title	Description
OG000	CFD4870g Sham	Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.
OG001	CFD4870g Lampalizumab	Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.
OG002	GX29455 Sham	Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
OG003	GX29455 Lampalizumab	Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.
OG004	All Participants	All participants in the study received lampalizumab 10 mg, ITV, Q4W.

Units	Counts
Participants	OG00029 OG00160 OG00217 OG003

Title

Denominators

Categories

Ocular AEs in Study Eye

Title	Measurements
	OG00062.1 OG00178.3 OG00252.9 OG003

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	CFD4870g Sham	Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study.	1	29	16	29	24	29
EG001	CFD4870g Lampalizumab	Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study.	6	60	40	60	56	60
EG002	GX29455 Sham	Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.	0	17	5	17	16	17
EG003	GX29455 Lampalizumab	Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study.	1	53	9	53	41	53
EG004	All Participants	All participants in the study received lampalizumab 10 mg, ITV, Q4W.	8	159	70	159	137	159

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG0030 affected53 at risk EG0042 affected159 at risk
Angina pectoris	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Cardiac perforation	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Ventricle rupture	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Blindness transient	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Cataract	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Retinal detachment	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0012 affected60 at risk EG0021 affected17 at risk EG003
Visual impairment	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Vitritis	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Cellulitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Diverticulitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Infected lymphocele	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Pneumonia	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Sepsis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Septic shock	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Urosepsis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Foreign body aspiration	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Genital injury	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Pubis fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Intraocular pressure increased	Investigations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Lung carcinoma cell type unspecified stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Epilepsy	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Syncope	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Hypertension	Vascular disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Varicose vein	Vascular disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Asthenia	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Chest pain	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Death	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Fatigue	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Peripheral swelling	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Pyrexia	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG0032 affected53 at risk EG0046 affected159 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG00110 affected60 at risk EG0021 affected17 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0004 affected29 at risk EG00118 affected60 at risk EG0023 affected17 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0004 affected29 at risk EG00113 affected60 at risk EG0022 affected17 at risk EG003
Eye pain	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG00114 affected60 at risk EG0020 affected17 at risk EG003
Cataract	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0019 affected60 at risk EG0020 affected17 at risk EG003
Posterior capsule opacification	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG0013 affected60 at risk EG0022 affected17 at risk EG003
Vitreous detachment	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0004 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Vitreous floaters	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0016 affected60 at risk EG0021 affected17 at risk EG003
Dry eye	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0016 affected60 at risk EG0020 affected17 at risk EG003
Punctate keratitis	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0017 affected60 at risk EG0022 affected17 at risk EG003
Visual impairment	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0015 affected60 at risk EG0021 affected17 at risk EG003
Cataract nuclear	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Blepharitis	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Neovascular age-related macular degeneration	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Vision blurred	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Iritis	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0021 affected17 at risk EG003
Blindness transient	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Cataract subcapsular	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0014 affected60 at risk EG0021 affected17 at risk EG003
Dry age-related macular degeneration	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Eye pruritus	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Lacrimation increased	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Foreign body sensation in eyes	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Blepharochalasis	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Ocular hypertension	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Open angle glaucoma	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Trichiasis	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Corneal erosion	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Corneal opacity	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Corneal oedema	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Macular oedema	Eye disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0019 affected60 at risk EG0021 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0017 affected60 at risk EG0020 affected17 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Oedema peripheral	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Pain	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Asthenia	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Injection site pain	General disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0008 affected29 at risk EG00111 affected60 at risk EG0021 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG00113 affected60 at risk EG0021 affected17 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0004 affected29 at risk EG0019 affected60 at risk EG0023 affected17 at risk EG003
Bronchitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0005 affected29 at risk EG0017 affected60 at risk EG0020 affected17 at risk EG003
Sinusitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0004 affected29 at risk EG0015 affected60 at risk EG0021 affected17 at risk EG003
Pneumonia	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0016 affected60 at risk EG0021 affected17 at risk EG003
Herpes zoster	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Influenza	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0016 affected60 at risk EG0021 affected17 at risk EG003
Cystitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Ear infection	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0014 affected60 at risk EG0021 affected17 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Tooth infection	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Cellulitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Diverticulitis	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Oral herpes	Infections and infestations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0007 affected29 at risk EG00113 affected60 at risk EG0023 affected17 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Intraocular pressure increased	Investigations	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG0016 affected60 at risk EG0020 affected17 at risk EG003
Blood glucose increased	Investigations	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0015 affected60 at risk EG0021 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0014 affected60 at risk EG0021 affected17 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG0012 affected60 at risk EG0020 affected17 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Bone swelling	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0003 affected29 at risk EG0012 affected60 at risk EG0021 affected17 at risk EG003
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Blepharal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Headache	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0018 affected60 at risk EG0020 affected17 at risk EG003
Dementia	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Dizziness	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected60 at risk EG0021 affected17 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0012 affected60 at risk EG0021 affected17 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Migraine	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Depression	Psychiatric disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Anxiety	Psychiatric disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0020 affected17 at risk EG003
Hallucination, visual	Psychiatric disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected60 at risk EG0021 affected17 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0014 affected60 at risk EG0020 affected17 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0015 affected60 at risk EG0020 affected17 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0013 affected60 at risk EG0021 affected17 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0012 affected60 at risk EG0021 affected17 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected60 at risk EG0020 affected17 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected60 at risk EG0020 affected17 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA, version 20.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Cataract operation	Surgical and medical procedures	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003
Hypertension	Vascular disorders	MedDRA, version 20.1	Systematic Assessment	EG0002 affected29 at risk EG0017 affected60 at risk EG0021 affected17 at risk EG003
Hypotension	Vascular disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0014 affected60 at risk EG0021 affected17 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected60 at risk EG0021 affected17 at risk EG003

Certain Agreements

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