A Study of Ranibizumab Administered Monthly or on an As-n... | NCT00891735

ID	Type	Description	Link
GX01511	Other Identifier	Hoffmann-La Roche

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranibizumab 0.5 mg monthly	Experimental	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.	Drug: Ranibizumab
Ranibizumab 2.0 mg monthly	Experimental	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months.	Drug: Ranibizumab
Ranibizumab 0.5 mg as-needed (pro re nata [PRN])	Experimental	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.	Drug: Ranibizumab
Ranibizumab 2.0 mg as-needed (pro re nata [PRN])	Experimental	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.	Drug: Ranibizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab	Drug	Sterile solution for intravitreal injection.	Ranibizumab 0.5 mg as-needed (pro re nata [PRN]) Ranibizumab 0.5 mg monthly Ranibizumab 2.0 mg as-needed (pro re nata [PRN])

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12	BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.	Baseline to Month 12

Secondary Outcomes

Measure	Description	Time Frame
Number of Ranibizumab Injections up to But Not Including Month 12		Baseline to Month 12
Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12	BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.

Ocular Inclusion Criteria (Study Eye)

Best corrected visual acuity (BCVA), using Early Treatment Diabetic Retinopathy Study (ETDRS) charts, of 20/40-20/320 (Snellen equivalent).
Choroidal neovascularization (CNV) lesions with classic CNV component, occult CNV, or with some classic CNV component were permissible.
Total area of lesion < 12 disc area or 30.48 mm^2.

Exclusion Criteria:

History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye.
Prior treatment with Visudyne(R), external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye.
Previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation) in the study eye.
Previous treatment or participation in a clinical trial involving anti-angiogenic drugs (Avastin(R), anecortave acetate, protein kinase C inhibitors, etc), in the non-study eye within 3 months of Day 0 (first day of treatment). The patient may not have received Lucentis(R) or Macugen(R) in the non-study eye within 7 days of Day 0.
Treatment with Visudyne(R) in the non-study eye < 7 days preceding Day 0.
Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm^2) in size.
Subfoveal fibrosis or atrophy in the study eye.
CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
Retinal pigment epithelial tear involving the macula in the study eye.
Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity (BCVA) over the 24-month study period.
Uncontrolled blood pressure.
Atrial fibrillation not managed by patient's primary care physician or cardiologist within 3 months of screening visit.
History of stroke within the last 3 months of screening visit.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
Current treatment for active systemic infection.
Active malignancy.
History of allergy to fluorescein, not amenable to treatment.
Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
39287532	Derived	Tong N, Fan W, Su L, Ebraheem A, Uji A, Marion K, Sadda S. RELATIONSHIP BETWEEN OPTICAL COHERENCE TOMOGRAPHY BIOMARKERS AND NUMBER OF INTRAVITREAL RANIBIZUMAB INJECTIONS IN EYES WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN THE HARBOR STUDY. Retina. 2024 Oct 1;44(10):1696-1703. doi: 10.1097/IAE.0000000000004171.
37079518

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
FG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
BG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
BG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
BG003	Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12

BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.

Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.

Posted

Mean

Standard Deviation

Letters

Baseline to Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
OG003	Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.

Units	Counts
Participants	OG000275 OG001274 OG002275 OG003

Title

Denominators

Categories

Title	Measurements
	OG00010.1± 13.3 OG0019.2± 14.6 OG0028.2± 13.3 OG003

Secondary

Number of Ranibizumab Injections up to But Not Including Month 12

All treated patients. Observed data were used with no imputation.

Posted

Mean

Standard Deviation

Injections

Baseline to Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
OG003	Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.

Secondary

Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12

BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.

Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.

Posted

Number

95% Confidence Interval

Percentage of patients

Baseline to Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.

Secondary

Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12

VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.

Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.

Posted

Number

95% Confidence Interval

Percentage of patients

Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.

Secondary

Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12

The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness < 270 µm.

Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.

Posted

Number

95% Confidence Interval

Percentage of patients

Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.

Secondary

Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12

Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).

Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.

Posted

Mean

Standard Deviation

µm

Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
OG003

Secondary

Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12

Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).

Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.

Posted

Mean

Standard Deviation

mm^3

Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
OG003

Secondary

Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12

The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm^2.

Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.

Posted

Mean

Standard Deviation

Disc area units

Baseline to Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
OG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
OG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ranibizumab 0.5 mg Monthly	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.	66	274	240	274
EG001	Ranibizumab 2.0 mg Monthly	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.	54	274	243	274
EG002	Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.	57	275	250	275
EG003	Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])	Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.	54	272	239	272

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG0030 affected272 at risk
Hypocoagulable state	Blood and lymphatic system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0011 affected274 at risk EG0024 affected275 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0003 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0006 affected274 at risk EG0011 affected274 at risk EG0022 affected275 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0022 affected275 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0005 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Sinus arrest	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Tachyarrhythmia	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Age-related macular degeneration	Eye disorders	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Corneal oedema	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Iridocyclitis	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Macular degeneration	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Macular hole	Eye disorders	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Retinal artery occlusion	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Retinal tear	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Retinal vein occlusion	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0000 affected274 at risk EG0013 affected274 at risk EG0022 affected275 at risk EG003
Vitreous floaters	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Large intestinal harmorrhage	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Pancreatic mass	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Asthenia	General disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Chest pain	General disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0010 affected274 at risk EG0022 affected275 at risk EG003
Death	General disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Device dislocation	General disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Device failure	General disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Medical device complication	General disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Oedema peripheral	General disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Pain	General disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Gallbladder pain	Hepatobiliary disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Brain abscess	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Breast infection	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Bronchitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Cellulitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Empyema	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Endocarditis bacterial	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment	Study eye	EG0002 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Lung abscess	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Pneumonia	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0005 affected274 at risk EG0015 affected274 at risk EG0026 affected275 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Sepsis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Septic shock	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0012 affected274 at risk EG0021 affected275 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0023 affected275 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0022 affected275 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Post procedural heamatoma	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Splenic injury	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Splenic rupture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Blood creatinine increased	Investigations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Urine output decreased	Investigations	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (14.0)	Systematic Assessment		EG0003 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0012 affected274 at risk EG0020 affected275 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0023 affected275 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Lung adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Non-Hodgkin's lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Splenic marginal zone lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0011 affected274 at risk EG0022 affected275 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Convulsion	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Dementia	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Nerve compression	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Paraparesis	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Presyncope	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Syncope	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0012 affected274 at risk EG0021 affected275 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Depression	Psychiatric disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Hallucination	Psychiatric disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Somatic delusion	Psychiatric disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0022 affected275 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0002 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Thrombosis prophylaxis	Surgical and medical procedures	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0011 affected274 at risk EG0022 affected275 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0021 affected275 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Hypertension	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0000 affected274 at risk EG0011 affected274 at risk EG0020 affected275 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG0000 affected274 at risk EG0010 affected274 at risk EG0021 affected275 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG0001 affected274 at risk EG0010 affected274 at risk EG0020 affected275 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Age-related macular degeneration	Eye disorders	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG0008 affected274 at risk EG00115 affected274 at risk EG00215 affected275 at risk EG00313 affected272 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG00063 affected274 at risk EG00151 affected274 at risk EG00248 affected275 at risk EG003
Detachment of retinal pigment epithelium	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0004 affected274 at risk EG0014 affected274 at risk EG00217 affected275 at risk EG003
Eye pain	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG00015 affected274 at risk EG00125 affected274 at risk EG00216 affected275 at risk EG003
Macular degeneration	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG00012 affected274 at risk EG0018 affected274 at risk EG00218 affected275 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG0006 affected274 at risk EG0017 affected274 at risk EG00214 affected275 at risk EG003
Vitreous detachment	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG00022 affected274 at risk EG00121 affected274 at risk EG00216 affected275 at risk EG003
Vitreous floaters	Eye disorders	MedDRA (14.0)	Systematic Assessment	Study eye	EG00026 affected274 at risk EG00115 affected274 at risk EG00211 affected275 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG00017 affected274 at risk EG00110 affected274 at risk EG00217 affected275 at risk EG003
Sinusitis	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG00012 affected274 at risk EG0017 affected274 at risk EG00227 affected275 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (14.0)	Systematic Assessment		EG00015 affected274 at risk EG00114 affected274 at risk EG00217 affected275 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (14.0)	Systematic Assessment		EG00014 affected274 at risk EG00112 affected274 at risk EG0028 affected275 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Systematic Assessment		EG0005 affected274 at risk EG00110 affected274 at risk EG0026 affected275 at risk EG003
Hypertension	Vascular disorders	MedDRA (14.0)	Systematic Assessment		EG00014 affected274 at risk EG00120 affected274 at risk EG00221 affected275 at risk EG003
Macular degeneration	Eye disorders	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG00014 affected274 at risk EG00112 affected274 at risk EG00211 affected275 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG00012 affected274 at risk EG00115 affected274 at risk EG0026 affected275 at risk EG003
Vitreous detachment	Eye disorders	MedDRA (14.0)	Systematic Assessment	Fellow eye	EG00020 affected274 at risk EG00124 affected274 at risk EG00217 affected275 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85020	United States

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

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