An Open Label Trial to Investigate Macugen for the Preser... | NCT00327470

Label	Type	Description	Intervention Names
Open Label	Experimental		Drug: Pegaptanib Sodium 0.3 mg

Name	Type	Description	Arm Group Labels	Other Names
Pegaptanib Sodium 0.3 mg	Drug	Pegaptanib Sodium dosed every 6 weeks in affected eye.	Open Label

Measure	Description	Time Frame
Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions	The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters from Baseline, gaining >=0 or >=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.	Baseline through Week 54

Measure	Description	Time Frame
Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions	The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey ETDRS charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Graz		A-8036	Austria
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
22872673	Derived	Chakravarthy U, Staurenghi G, Kwok K, Tressler CS, Buggage R; PERSPECTIVES Study Group. Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: findings of the PERSPECTIVES study. Br J Ophthalmol. 2012 Oct;96(10):1351-4. doi: 10.1136/bjophthalmol-2011-301444. Epub 2012 Aug 7. No abstract available.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Early Age-related Macular Degeneration (AMD)	Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

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

Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions

The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters from Baseline, gaining >=0 or >=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.

The modified intent-to-treat (MITT) population included all subjects in the safety population who had a Baseline distance VA measurement and at least 1 post-Baseline VA measurement. Last observation carried forward (LOCF). Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline through Week 54

ID	Title	Description
OG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
OG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Units	Counts
Participants	OG000107 OG001178

Title

Denominators

Categories

Title	Measurements
	OG000-4.30± 14.57 OG001-5.51± 15.08

Secondary

Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions

The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey ETDRS charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.

MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline through Week 102, Week 54 through Week 102

ID	Title	Description
OG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
OG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Secondary

Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions

Near VA was measured with the modified Bailey-Lovie near-word reading charts at a distance of 25 centimeters using a +3.50 reading addition worn over the protocol refraction providing the best-corrected distance VA. The reading charts test the smallest word size identifiable from 0.0 logarithmic of the minimum angle of resolution (logMAR) to 1.6 logMAR. logMAR is the logarithm of the minimum angle of resolution. The ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values >0.00 indicate vision poorer than ideal and values <0.0 indicate vision greater than ideal.

MITT LOCF. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline through Week 54, Baseline through Week 102

ID	Title	Description
OG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
OG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Secondary

Mean Change in Reading Speed

For assessment of reading speed, subjects were asked to read a print steadily, without stopping or interruption, at a comfortable pace. On commencing reading, a timer was activated. The timer was stopped when the subject had finished reading all of the words on the chart or at 2 minutes, whichever was sooner. Only the total number of words read correctly was recorded. The time recorded for the reading speed test was the time required for the subject to finish reading all of the words on the chart in minutes and seconds (maximum 2 minutes).

MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.

Posted

Mean

Standard Deviation

Correctly read words per minute

Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

ID	Title	Description
OG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
OG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Secondary

Mean Change From Baseline in Contrast Sensitivity

Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.

MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.

Posted

Mean

Standard Deviation

Correctly read letters

Baseline through Week 54, Baseline through Week 102

ID	Title	Description
OG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
OG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Secondary

Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score

Subject reported vision-related functioning and Quality of Life (QoL) as measured using the 25 item NEI-VFQ-25. Items are grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. A positive change represents an increase in function/health, a negative change represents a decrease in function/health.

MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

ID	Title	Description
OG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
OG001	Established AMD

Secondary

Mean Change in Euro QoL Questionnaire (EQ-5D) Score

The EQ-5D is a validated, standardized QoL instrument assessing general health status based on the preference of a UK general population. It consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems"). A subject's responses to these domains were mapped to a corresponding score of the EQ-5D index.

MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

ID	Title	Description
OG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
OG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Angina pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0010 affected179 at risk
Angina unstable	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Bradycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Palpitations	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Eye haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Iridocyclitis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Open angle glaucoma	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Retinal detachment	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Uveitis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Visual acuity reduced	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Vitritis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Injection site injury	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Endophthalmitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0012 affected179 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Herpes zoster	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Loss of consciousness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Eye operation	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Meniscus operation	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Phlebitis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0014 affected179 at risk
Splenic lesion	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Arrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Cardiac failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Palpitations	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Corneal dystrophy	Congenital, familial and genetic disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Deafness	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0012 affected179 at risk
Anterior chamber cell	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0013 affected179 at risk
Anterior chamber flare	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Anterior chamber pigmentation	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Aphakia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Blepharitis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0012 affected179 at risk
Blepharitis allergic	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Blindness	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0012 affected179 at risk
Blindness transient	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Blindness unilateral	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0010 affected179 at risk
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0014 affected179 at risk
Cataract nuclear	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Cataract subcapsular	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Chalazion	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Choroidal neovascularisation	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0016 affected179 at risk
Ciliary body haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG00017 affected107 at risk EG00116 affected179 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0007 affected107 at risk EG0014 affected179 at risk
Conjunctival oedema	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Conjunctivitis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0007 affected107 at risk EG0018 affected179 at risk
Corneal deposits	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Corneal disorder	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0012 affected179 at risk
Corneal epithelium defect	Eye disorders	MedDRA 12.0	Systematic Assessment	EG00010 affected107 at risk EG0014 affected179 at risk
Corneal erosion	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Corneal oedema	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected107 at risk EG0017 affected179 at risk
Corneal opacity	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Detachment of retinal pigment epithelium	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Dry eye	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0013 affected179 at risk
Episcleritis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Erythema of eyelid	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Eye discharge	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0014 affected179 at risk
Eye disorder	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Eye haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0012 affected179 at risk
Eye irritation	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0015 affected179 at risk
Eye pain	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0009 affected107 at risk EG0019 affected179 at risk
Eye pruritus	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Eyelid oedema	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected107 at risk EG0010 affected179 at risk
Glaucoma	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Hyalosis asteroid	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Hyphaema	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Iridocyclitis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Keratoconjunctivitis sicca	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Lacrimation increased	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0006 affected107 at risk EG0012 affected179 at risk
Lens disorder	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Macular degeneration	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0015 affected179 at risk
Maculopathy	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Metamorphopsia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0011 affected179 at risk
Myodesopsia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0006 affected107 at risk EG0014 affected179 at risk
Ocular hyperaemia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0013 affected179 at risk
Ocular hypertension	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Photophobia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0011 affected179 at risk
Photopsia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Posterior capsule opacification	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0013 affected179 at risk
Punctate keratitis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Retinal artery spasm	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Retinal exudates	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Retinal haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0019 affected179 at risk
Retinal oedema	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Retinal pigment epithelial tear	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Scleral haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Vision blurred	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0011 affected179 at risk
Visual acuity reduced	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0019 affected179 at risk
Visual impairment	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0014 affected179 at risk
Vitreous detachment	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0011 affected179 at risk
Vitreous disorder	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0007 affected107 at risk EG0016 affected179 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0013 affected179 at risk
Vitreous opacities	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Vitritis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Colitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0014 affected179 at risk
Dental caries	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Dental plaque	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0012 affected179 at risk
Duodenogastric reflux	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Influenza like illness	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Injection site haemorrhage	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0014 affected179 at risk
Injection site irritation	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Injection site pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0014 affected179 at risk
Injection site reaction	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Polyp	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Therapeutic response unexpected	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0018 affected179 at risk
Candidiasis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Cystitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Dacryocystitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Erysipelas	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Eye infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Fungal skin infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Gastrointestinal fungal infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Gingival infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Herpes virus infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Herpes zoster	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Hordeolum	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Incision site infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0015 affected179 at risk
Keratitis herpetic	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Laryngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0014 affected179 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0009 affected107 at risk EG00110 affected179 at risk
Otitis media	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Pharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Pulpitis dental	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Rhinitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Tooth abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Tooth infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0015 affected179 at risk
Urethritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0011 affected179 at risk
Viral infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Accidental exposure	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0013 affected179 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Post procedural discomfort	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Blood glucose increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Blood pressure abnormal	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Blood pressure increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Blood uric acid increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Haemoglobin decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Intraocular pressure decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Intraocular pressure increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0008 affected107 at risk EG00115 affected179 at risk
Ultrasound Doppler normal	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Hyperhomocysteinaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0012 affected179 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0013 affected179 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected107 at risk EG0012 affected179 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Jaw cyst	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0014 affected179 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0014 affected179 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Aphasia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Balance disorder	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected107 at risk EG0017 affected179 at risk
Hemicephalalgia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Hypertonia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Hyposmia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Neuralgia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Presyncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 events0 affected179 at risk
Sciatica	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Visual field defect	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0012 affected179 at risk
Confusional state	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Depressed mood	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0012 affected179 at risk
Nervousness	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Reading disorder	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Sleep disorder	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Renal cyst	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0014 affected179 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0011 affected179 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected107 at risk EG0010 affected179 at risk
Abscess drainage	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Bladder neoplasm surgery	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Curetting of chalazion	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk
Gingival operation	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Malignant tumour excision	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Haematoma	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0013 affected179 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected107 at risk EG00110 affected179 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Phlebitis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected107 at risk EG0010 affected179 at risk
Varicose vein	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected107 at risk EG0011 affected179 at risk

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases
D014603	Uveal Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
BG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).			23	107	68	107
EG001	Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).			32	179	120	179

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization