Randomized, Single-Masked, Long-Term, Safety and Tolerabi... | NCT00527423

Name	Class
Bayer	INDUSTRY

Label	Type	Description	Intervention Names
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)	Experimental		Drug: VEGF Trap Eye

Name	Type	Description	Arm Group Labels	Other Names
VEGF Trap Eye	Drug	Intravitreal injection	Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)

Measure	Description	Time Frame
Number of Participants With Adverse Events (AE)	Number of participants with AEs summarized by category	Baseline of this study to Wk 152

Measure	Description	Time Frame
Frequency (Number of Injections)	Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).	Baseline of this study to Wk 152
Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

ID	Title	Description
FG000	Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg	The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.

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

Number of Participants With Adverse Events (AE)

Number of participants with AEs summarized by category

Posted

Number

participants

Baseline of this study to Wk 152

ID	Title	Description
OG000	Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg	The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.

Units	Counts
Participants	OG000157

Title

Denominators

Categories

Number of participants with any AE

Title	Measurements
	OG000154

Any ocular AE (Study eye and Fellow eye)

Title	Measurements
	OG000138

Any non ocular AE

Secondary

Frequency (Number of Injections)

Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).

A total of 1116 PRN injections were administered into the study eyes of 135 participants between baseline of this study to Week 152 (end of treatment). Of the 157 enrolled participants, 22 received no injections, and 15 received 1 injection.

Posted

Median

Full Range

Injections

Baseline of this study to Wk 152

ID	Title	Description
OG000	Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg	The study consisted of a treatment period from day 1 to week 152 (end of treatment), and a 4-week follow-up visit at week 156 (end of study). Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values

Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.

Posted

Mean

Standard Deviation

letters read

Baseline of original study to Wk 156

ID	Title	Description
OG000	Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg	The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0004 affected157 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Head and neck cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Renal cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0005 affected157 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Hypertension	Vascular disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Hypotension	Vascular disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Orthostatic hypotension	Vascular disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Goitre	Endocrine disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Lens dislocation	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG0001 affected157 at risk
Retinal oedema	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Study Eye	EG0001 affected157 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Eructation	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Chest pain	General disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Gait disturbance	General disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Metaplasia	General disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0007 affected157 at risk
Atrioventricular block	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Bradycardia	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Coronary artery disease	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Pericarditis	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Sarcoidosis	Immune system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Bronchitis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Cellulitis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Enteritis infectious	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Pneumonia	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0005 affected157 at risk
Sepsis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Viral infection	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Accident	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Study Eye	EG0001 affected157 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0007 affected157 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Intraocular pressure increased	Investigations	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG0001 affected157 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0003 affected157 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0004 affected157 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Dementia	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Dizziness	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Headache	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Lacunar infarction	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Presyncope	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Syncope	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Hallucination	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Mental disorder	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Mental status changes	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0002 affected157 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0001 affected157 at risk
Visual acuity reduced	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Study Eye	EG0004 affected157 at risk
Retinal haemorrhage	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Study Eye	EG0002 affected157 at risk
Cataract	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Study Eye	EG0001 affected157 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0008 affected157 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00015 affected157 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00012 affected157 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00012 affected157 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk
Hypertension	Vascular disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00026 affected157 at risk
Age-related macular degeneration	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00018 affected157 at risk
Blepharitis	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00013 affected157 at risk
Cataract	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00021 affected157 at risk
Cataract nuclear	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG0009 affected157 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00012 affected157 at risk
Detachment of retinal pigment epithelium	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG0008 affected157 at risk
Dry eye	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00010 affected157 at risk
Eye pain	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG0008 affected157 at risk
Eye pruritus	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Study Eye	EG0008 affected157 at risk
Posterior capsule opacification	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Study Eye	EG00010 affected157 at risk
Retinal haemorrhage	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00019 affected157 at risk
Visual acuity reduced	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00013 affected157 at risk
Vitreous detachment	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG00011 affected157 at risk
Vitreous floaters	Eye disorders	MedDRA Version 14.1	Non-systematic Assessment	Ocular AE Fellow Eye	EG0008 affected157 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00012 affected157 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00016 affected157 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00014 affected157 at risk
Seasonal allergy	Immune system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00015 affected157 at risk
Bronchitis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG00017 affected157 at risk
Influenza	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG00010 affected157 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG00026 affected157 at risk
Sinusitis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG00016 affected157 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG00024 affected157 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment		EG00025 affected157 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG00010 affected157 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment		EG00029 affected157 at risk
Blood glucose increased	Investigations	MedDRA Version 14.1	Non-systematic Assessment		EG00013 affected157 at risk
Blood pressure increased	Investigations	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk
Protein urine present	Investigations	MedDRA Version 14.1	Non-systematic Assessment		EG00013 affected157 at risk
White blood cell count increased	Investigations	MedDRA Version 14.1	Non-systematic Assessment		EG00012 affected157 at risk
White blood cells urine positive	Investigations	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk
Dizziness	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00010 affected157 at risk
Headache	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0008 affected157 at risk
Depression	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00014 affected157 at risk
Insomnia	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00013 affected157 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG00014 affected157 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment		EG0009 affected157 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Peoria	Arizona	85381	United States

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases