Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT... | NCT01922102

Label	Type	Description	Intervention Names
Group I	Experimental	0.5 mg ranibizumab driven by visual acuity stability criteria	Drug: Ranibizumab 0.5mg
Group II	Experimental	0.5 mg ranibizumab driven by disease activity criteria	Drug: Ranibizumab 0.5 mg
Group III	Active Comparator	verteporfin PDT	Drug: Verteporfin PDT

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab 0.5mg	Drug	0.5 mg ranibizumab (intravitreal injections)	Group I

Measure	Description	Time Frame
Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3	Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.	From Baseline to Month 3

Measure	Description	Time Frame
Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6	Best corrected visual acuity (BCVA) was tested using the early treatment diabetic retinopathy study (ETDRS) VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 6.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Beijing	Beijing Municipality	100191	China
Novartis Investigative Site

ID	Title	Description
FG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
FG001	Group II	0.5 mg ranibizumab driven by disease activity criteria

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 BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3

Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.

Full Analysis Set (FAS): consisted of all patients to whom study treatment were assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization.

Posted

Mean

Standard Deviation

ETDRS letters

From Baseline to Month 3

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment

Units	Counts
Participants	OG000182 OG001184 OG00291

Title

Denominators

Categories

Baseline

- ParticipantsOG000181
- ParticipantsOG001184
- ParticipantsOG00289

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT > 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT > 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.	Cochran-Mantel-Haenszel		<0.001	Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.	Mean Difference (Net)	5.2			2-Sided	95	3.3	7.1			Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.

Secondary

Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6

Best corrected visual acuity (BCVA) was tested using the early treatment diabetic retinopathy study (ETDRS) VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.

Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 6.

Full Analysis Set (FAS): Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization.

FAS, modified last observation carried forward (LOCF), for comparison between ranibizumab treatment groups.): consisted of all patients to whom study treatment were assigned.

Posted

Mean

Standard Deviation

ETDRS letters

From Baseline to Month 6

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria

Secondary

The Average Change in BCVA Score From Baseline to Month 1 Through Month 12

Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.

FAS, modified LOCF for comparison between ranibizumab treatment groups.

Posted

Mean

Standard Deviation

ETDRS letters

From Baseline to Month 12

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment.

Secondary

Mean Change From Baseline in Visual Acuity Over Time

FAS

Posted

Mean

Standard Deviation

ETDRS letters

Change from baseline at months 3, 6, and 12

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment

Units	Counts

Secondary

Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye

ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.

FAS

Posted

Number

Participants

From Baseline to Month 12

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment

Units	Counts
Participants

Secondary

Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT)

Central sub-field thickness (CSFT) is a variable assessed via Optical Coherence Tomography (OCT). OCT was performed prior to any study drug administration to assess presence of intra, subretinal fluid, or increase of CSFT.

Posted

Mean

Standard Deviation

micrometer

Baseline, Month 3, Month 6, and Month 12

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment

Units	Counts
Participants

Secondary

Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12

CNV leakage is assessed via fluorescein angiography (center involvement) category: definite, questionable, absent, can't grade, and missing.

FAS

Posted

Number

Participants

From Baseline until Month 12

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment

Units	Counts
Participants

Secondary

NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12

The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.

FAS

Posted

Mean

Standard Deviation

Composite score

Change from baseline at month 3, 6 and 12

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment

Secondary

Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups

To assess treatment pattern with ranibizumab

Safety Set: all patients who received at least one application of study treatment & had at least one post-Baseline safety assessment. Patients were analyzed according to treatment received. One patient randomized to vPDT Group III received one ranibizumab injection prior to Month 3; this patient was analyzed under Group II in Safety Set

Posted

Mean

Standard Deviation

Injections

From Baseline to Month 12

ID	Title	Description
OG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
OG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
OG002	Group III With 0.5mg Ranibizumab	verteporfin PDT with 0.5 mg ranibizumab from month 3
OG003	Group III Without 0.5mg Ranibizumab	verteporfin PDT without 0.5 mg ranibizumab from month 3

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG0030 affected14 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Retinal detachment (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Retinal detachment (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Rectal polyp	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Anal abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Appendicitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Cellulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Endophthalmitis (Study eye)	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Pharyngitis bacterial	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Physical examination abnormal	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Shock hypoglycaemic	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Oligoastrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Syncope	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Bladder hyperaemia	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Henoch-Schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG0031 affected14 at risk
Palpitations	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Cataract (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Choroidal neovascularisation (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0013 affected185 at risk EG0021 affected75 at risk EG003
Choroidal neovascularisation (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Conjunctival deposit (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Conjunctival deposit (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Conjunctival haemorrhage (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0008 affected182 at risk EG00114 affected185 at risk EG0022 affected75 at risk EG003
Conjunctival hyperaemia (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Conjunctivitis allergic (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Conjunctivitis allergic (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Diplopia (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Dry eye (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Dry eye (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Exophthalmos (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Exophthalmos (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Eye pain (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0004 affected182 at risk EG0013 affected185 at risk EG0020 affected75 at risk EG003
Eye pain (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0006 affected182 at risk EG0015 affected185 at risk EG0021 affected75 at risk EG003
Eye pruritus (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Eye swelling (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Eye swelling (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Foreign body sensation in eyes (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Macular fibrosis (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Macular hole (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Metamorphopsia (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Metamorphopsia (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Ocular discomfort (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Ocular discomfort (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Ocular hypertension (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Pathologic myopia (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Photopsia (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Posterior capsule opacification (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Retinal haemorrhage (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0014 affected185 at risk EG0020 affected75 at risk EG003
Retinal haemorrhage (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Vision blurred (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0016 affected185 at risk EG0020 affected75 at risk EG003
Visual acuity reduced (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Visual acuity reduced (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0022 affected75 at risk EG003
Visual impairment (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Vitreous floaters (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Vitreous opacities (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Vitreous opacities (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Xerophthalmia (Fellow eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0006 affected182 at risk EG0017 affected185 at risk EG0021 affected75 at risk EG003
Xerophthalmia (Study eye)	Eye disorders	MedDRA (19.0)	Systematic Assessment	EG0007 affected182 at risk EG0017 affected185 at risk EG0022 affected75 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0022 affected75 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Glossitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Loose tooth	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0004 affected182 at risk EG0011 affected185 at risk EG0023 affected75 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Chest discomfort	General disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Peripheral swelling	General disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Pyrexia	General disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0013 affected185 at risk EG0020 affected75 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0022 affected75 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0022 affected75 at risk EG003
Allergy to chemicals	Immune system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Bronchitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0005 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Conjunctivitis (Fellow eye)	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0016 affected185 at risk EG0023 affected75 at risk EG003
Conjunctivitis (Study eye)	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0015 affected185 at risk EG0023 affected75 at risk EG003
Cystitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Gastroenteritis shigella	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Hordeolum (Study eye)	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Lung infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00017 affected182 at risk EG00120 affected185 at risk EG0028 affected75 at risk EG003
Periodontitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0013 affected185 at risk EG0020 affected75 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Rhinitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00014 affected182 at risk EG00112 affected185 at risk EG0026 affected75 at risk EG003
Urethritis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0004 affected182 at risk EG0012 affected185 at risk EG0023 affected75 at risk EG003
Vaginal infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0004 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0004 affected182 at risk EG0011 affected185 at risk EG0020 affected75 at risk EG003
Bacterial test positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Blood glucose increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0016 affected185 at risk EG0023 affected75 at risk EG003
Blood pressure increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0022 affected75 at risk EG003
Blood uric acid increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0007 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Blood urine present	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0011 affected185 at risk EG0022 affected75 at risk EG003
Intraocular pressure increased (Fellow eye)	Investigations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0014 affected185 at risk EG0021 affected75 at risk EG003
Intraocular pressure increased (Study eye)	Investigations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0014 affected185 at risk EG0021 affected75 at risk EG003
Platelet count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Pregnancy test positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Protein urine present	Investigations	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0013 affected185 at risk EG0022 affected75 at risk EG003
Red blood cells urine positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Urine ketone body present	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Urine leukocyte esterase positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Visual acuity tests abnormal (Study eye)	Investigations	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0013 affected185 at risk EG0023 affected75 at risk EG003
White blood cell count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0013 affected185 at risk EG0021 affected75 at risk EG003
White blood cells urine positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0013 affected185 at risk EG0020 affected75 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0022 affected75 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0021 affected75 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0022 affected75 at risk EG003
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected185 at risk EG0020 affected75 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Dizziness	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Facial neuralgia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Headache	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0019 affected185 at risk EG0022 affected75 at risk EG003
Migraine	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Seizure	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0013 affected185 at risk EG0020 affected75 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Breast hyperplasia	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Breast swelling	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Menopausal symptoms	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0005 affected182 at risk EG00110 affected185 at risk EG0025 affected75 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0004 affected182 at risk EG0011 affected185 at risk EG0022 affected75 at risk EG003
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0002 affected182 at risk EG0010 affected185 at risk EG0020 affected75 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0011 affected185 at risk EG0021 affected75 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Diabetic vascular disorder	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Hyperaemia (Study eye)	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected185 at risk EG0021 affected75 at risk EG003
Hypertension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0007 affected182 at risk EG0012 affected185 at risk EG0023 affected75 at risk EG003

ID	Term
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D011166	Porphyrins
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria
BG001	Group II	0.5 mg ranibizumab driven by disease activity criteria
BG002	Group III	verteporfin PDT (driven by disease activity). Patients received vPDT on Day 1. From Month 3, based on disease activity vPDT, Ranibizumab 0.5 mg, or combo of Ranibizumab and vPDT was selected for treatment
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group I	0.5 mg ranibizumab driven by visual acuity stability criteria	7	182	102	182
EG001	Group II	0.5 mg ranibizumab driven by disease activity criteria	15	185	116	185
EG002	Group III With 0.5mg Ranibizumab	Visudyne PDT with 0.5mg ranibizumab from month 3	8	75	50	75
EG003	Group III Without 0.5mg Ranibizumab	Visudyne PDT without 0.5mg ranibizumab from month 3	0	14	8	14