Zimura in Participants With Geographic Atrophy Secondary... | NCT02686658

ID	Type	Description	Link
2015-003991-56	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Avacincaptad Pegol 1 mg [Part 1]	Experimental	Participants received 1 mg of Avacincaptad Pegol in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.	Drug: Avacincaptad Pegol
Avacincaptad Pegol 2 mg [Part 1]	Experimental	Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.	Drug: Avacincaptad Pegol
Sham [Part 1]	Sham Comparator	Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.	Other: Sham
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]	Experimental	Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.	Drug: Avacincaptad Pegol Other: Sham
Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]	Experimental	Participants received 4 mg of Avacincaptad Pegol in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Avacincaptad Pegol	Drug	Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection	Avacincaptad Pegol 1 mg [Part 1] Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]

Measure	Description	Time Frame
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.	Baseline and 12 months

Measure	Description	Time Frame
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study [ETDRS] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.

Eligibility Module

PubMed Identifier	Type	Citation	Retractions
32882310	Result	Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1.
39538001

Label	URL
Link to plain language summary of the study on the Trial Results Summaries website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Zimura 1 mg [Part 1]	Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months.
FG001	Zimura 2 mg [Part 1]

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 28, 2018	Jan 31, 2023

Arm/Group Information

ID	Title	Description
BG000	Zimura 1 mg [Part 1]	Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months.
BG001	Zimura 2 mg [Part 1]	Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months.
BG002	Sham [Part 1]	Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
BG003	Zimura 2 mg (Zimura 2mg+Sham) [Part 2]	Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months.
BG004	Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]	Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.
BG005	Sham (Sham+Sham) [Part 2]	Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
BG006	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence

The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.

This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.

Posted

Least Squares Mean

Standard Error

millimeters (mm)

Baseline and 12 months

ID	Title	Description
OG000	Zimura 2 mg [Part 1 & Part 2 Combined]	Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.
OG001	Sham [Part 1 & Part 2 Combined]	Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
OG002	Zimura 4 mg [Part 2]	Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.
OG003	Sham [Part 2]	Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.

Units	Counts
Participants	OG00067 OG001110 OG00283 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.292± 0.077 OG0010.402± 0.075 OG0020.321± 0.074 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Difference in least squares means between groups calculated as (Sham) minus (Zimura).	Model for repeated measures (MRM)		0.0072		Least Squares Mean Difference	0.110			2-Sided	95							Other	Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.

Secondary

Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters

The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study [ETDRS] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.

Posted

Least Squares Mean

Standard Error

ETDRS Letters

Baseline and 12 months

ID	Title	Description
OG000	Zimura 2 mg [Part 1 & Part 2 Combined]	Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.
OG001	Sham [Part 1 & Part 2 Combined]	Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
OG002

Secondary

Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters

The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.

Posted

Least Squares Mean

Standard Error

ETDRS Letters

Baseline and 12 months

ID	Title	Description
OG000	Zimura 2 mg [Part 1 & Part 2 Combined]	Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.
OG001	Sham [Part 1 & Part 2 Combined]	Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
OG002	Zimura 4 mg [Part 2]

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	Zimura 1 mg [Part 1]	Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months.	1	26	3	26	13	26
EG001	Zimura 2 mg [Part 1]	Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months.	0	25	4	25	13	25
EG002	Sham [Part 1]	Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.	0	26	7	26	10	26
EG003	Zimura 2 mg (Zimura 2mg+Sham) [Part 2]	Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months.	1	42	8	42	34	42
EG004	Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]	Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.	1	83	21	83	66	83
EG005	Sham (Sham+Sham) [Part 2]	Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.	1	84	21	84	49	84
EG006	Zimura (Any Dose) [Part 1 & Part 2 Combined]	Participants received a 1 mg, 2 mg, or 4 mg dose of Zimura in the study eye administered via 1 or 2 IVT injection(s) (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.	3	176	36	176	126	176
EG007	Sham [Part 1 & Part 2 Combined]	Participants received a Sham injection (or 2 Sham injections) of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.	1	110	28	110	59	110

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Iron deficiency anemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG0030 affected42 at risk EG004
Acute myocardial infarction	Cardiac disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Mitral valve stenosis	Cardiac disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Optic ischaemic neuropathy*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Retinal detachment*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Appendiceal mucocoele	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Cystitis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Groin abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Urosepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk EG0021 affected26 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Prostate cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Subclavian artery stenosis	Vascular disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Conjunctival haemorrhage *	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0002 affected26 at risk EG0012 affected25 at risk EG0021 affected26 at risk EG0039 affected42 at risk EG004
Neovascular age-related macular degeneration*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0003 affected26 at risk EG0012 affected25 at risk EG0022 affected26 at risk EG003
Conjunctival hyperaemia*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Punctate keratitis*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Eye pain*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Vitreous detachment*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0003 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Cataract*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0002 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Visual acuity reduced*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0012 affected25 at risk EG0020 affected26 at risk EG003
Conjunctival oedema*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Choroidal neovascularization*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0001 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Eye irritation*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Posterior capsule opacification*	Eye disorders	MedDRA 18.1	Systematic Assessment	* included study and fellow eye events	EG0000 affected26 at risk EG0012 affected25 at risk EG0020 affected26 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0002 affected26 at risk EG0010 affected25 at risk EG0022 affected26 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0013 affected25 at risk EG0020 affected26 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0002 affected26 at risk EG0011 affected25 at risk EG0020 affected26 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Influenza	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0012 affected25 at risk EG0021 affected26 at risk EG003
Rhinitis	Infections and infestations	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Intraocular pressure increased	Investigations	MedDRA 18.1	Systematic Assessment		EG0001 affected26 at risk EG0012 affected25 at risk EG0020 affected26 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0022 affected26 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0011 affected25 at risk EG0022 affected26 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment		EG0002 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment		EG0002 affected26 at risk EG0010 affected25 at risk EG0021 affected26 at risk EG003
Dementia	Nervous system disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0020 affected26 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment		EG0000 affected26 at risk EG0010 affected25 at risk EG0022 affected26 at risk EG003

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

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