Anti-VEGF vs. Prompt Vitrectomy for VH From PDR | NCT02858076

ID	Type	Description
EY14231	Other Grant/Funding Number	National Eye Institute
EY23207	Other Grant/Funding Number	National Eye Institute
EY18817	Other Grant/Funding Number	National Eye Institute

Name	Class
National Institutes of Health (NIH)	NIH
Regeneron Pharmaceuticals	INDUSTRY
National Eye Institute (NEI)	NIH

Label	Type	Description	Intervention Names
Intravitreous 2 mg aflibercept injections	Active Comparator	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.	Drug: 2-mg Intravitreous Aflibercept Injection
Prompt vitrectomy plus panretinal photocoagulation	Active Comparator	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.	Procedure: Prompt Vitrectomy Plus Panretinal Photocoagulation

Name	Type	Description	Arm Group Labels	Other Names
2-mg Intravitreous Aflibercept Injection	Drug	Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.

Measure	Description	Time Frame
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)	The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.	24 weeks

Measure	Description	Time Frame
E-ETDRS Visual Acuity Letter Score	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years Participants <18 years old are not being included because proliferative diabetic retinopathy is so rare in this age group that the diagnosis may be questionable.
Diagnosis of diabetes mellitus (type 1 or type 2)

Any one of the following will be considered to be sufficient evidence that diabetes is present:

Current regular use of insulin for the treatment of diabetes
Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
Documented diabetes by American Diabetes Association and/or World Health Organization criteria 4. Able and willing to provide informed consent. 5. Patient is willing and able to undergo vitrectomy within next 2 weeks and the vitrectomy can be scheduled within that time frame.

6. Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, for which intervention is deemed necessary.
- Note: Prior panretinal photocoagulation is neither a requirement nor an exclusion.
- Subhyaloid hemorrhage alone does not make an eye eligible; however, presence of subhyaloid hemorrhage in addition to the criteria above will not preclude participation provided the investigator is comfortable with either treatment regimen.
  
  7. Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 months to see if hemorrhage clears sufficiently with anti-vascular endothelial growth factor without having to proceed to vitrectomy).
  
  8. Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and at least light perception.
  
  9. Investigators should use particular caution when considering enrollment of an eye with visual acuity letter score 69 to 78 (approximate Snellen equivalent 20/32 to 20/40) to ensure that the need for vitrectomy and its potential benefits outweigh the potential risks.

Exclusion Criteria:

A potential participant is not eligible if any of the following exclusion criteria are present:
1. History of chronic renal failure requiring dialysis (including placement of fistula if performed in preparation for dialysis) or kidney transplant.
2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
4. A condition that, in the opinion of the investigator, would preclude participant undergoing elective vitrectomy surgery if indicated during the study.
5. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.
  
  • Note: participants cannot receive another investigational drug while participating in the study.
6. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine).
7. Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
8. If blood pressure is brought below 180/110 by anti-hypertensive treatment, potential participant can become eligible.
9. Systemic anti-vascular endothelial growth factor or pro-vascular endothelial growth factor treatment within 4 months prior to randomization.
  
  • These drugs cannot be used during the study.
10. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next two years.
  
  • Women who are potential participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
11. Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the two years.
12. Evidence of traction detachment involving or threatening the macula.
  
  • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
13. Evidence of rhegmatogenous retinal detachment.
  
  • If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
14. Evidence of neovascular glaucoma (iris or angle neovascularization is not an exclusion).
15. Known diabetic macular edema (DME), defined as either
16. Optical coherence tomography central subfield thickness (microns):
17. Zeiss Cirrus: ≥290 in women; ≥305 in men
18. Heidelberg Spectralis: ≥305 in women; ≥320 in men OR
19. Diabetic macular edema on clinical exam that the investigator believes currently requires treatment.
20. History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset.
21. History of intraocular corticosteroid treatment within 4 months prior to current vitreous hemorrhage onset or after onset.
22. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization.
23. History of vitrectomy.
24. History of YAG capsulotomy performed within 2 months prior to randomization.
25. Aphakia.
26. Uncontrolled glaucoma (in investigator's judgment).
27. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

Name	Affiliation	Role
Andrew Antoszyk, MD	Charlotte Eye, Ear, Nose and Throat Assoc., PA	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Retinal Diagnostic Center		Campbell	California	95008	United States
Macula & Retina Institute

PubMed Identifier	Type	Citation	Retractions
37972038	Derived	Beaulieu WT, Maguire MG, Antoszyk AN; DRCR Retina Network. Changes in activity impairment and work productivity after treatment for vitreous hemorrhage due to proliferative diabetic retinopathy: Secondary outcomes from a randomized controlled trial (DRCR Retina Network Protocol AB). PLoS One. 2023 Nov 16;18(11):e0293543. doi: 10.1371/journal.pone.0293543. eCollection 2023.
33956075

ID	Title	Description
FG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2 mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of vascular endothelial growth factor (VEGF) as well as to placental growth factor.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 28, 2016	Dec 22, 2020

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

E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)

The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up.

Posted

Mean

Standard Deviation

units on a scale

24 weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Units	Counts
Participants	OG00097 OG00198

Title

Denominators

Categories

Title	Measurements
	OG00059.3± 21.9 OG00163.0± 21.7

Secondary

E-ETDRS Visual Acuity Letter Score

Posted

Mean

Standard Deviation

units on a scale

4 Weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2 mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of vascular endothelial growth factor (VEGF) as well as to placental growth factor.
OG001	Vitrectomy With Panretinal Photocoagulation	For the prompt vitrectomy with panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Vitrectomy with Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

E-ETDRS Visual Acuity Letter Score

Posted

Mean

Standard Deviation

units on a scale

12 Weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

E-ETDRS Visual Acuity Letter Score

Posted

Mean

Standard Deviation

units on a scale

24 Weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

E-ETDRS Visual Acuity Letter Score

Posted

Mean

Standard Deviation

units on a scale

1-Year from participant randomization

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

E-ETDRS Visual Acuity Letter Score

Posted

Mean

Standard Deviation

units on a scale

2 Years

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)

Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up.

Posted

Mean

Standard Deviation

units on a scale

2-Years

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation

Secondary

Snellen Equivalent Range (Visual Acuity Score)

Posted

Count of Participants

Participants

4 weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

Snellen Equivalent Range (Visual Acuity Score)

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

Snellen Equivalent Range (Visual Acuity Score)

Posted

Count of Participants

Participants

24 weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

Snellen Equivalent Range (Visual Acuity Score)

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

Snellen Equivalent Range (Visual Acuity Score)

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

Recurrent Vitreous Hemorrhage

Assessed by the investigator and defined as presence of vitreous hemorrhage after a period of absence. Excludes eyes in which vitreous hemorrhage could not be assessed during follow-up.

Posted

Count of Participants

Participants

At any time through 2 years

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Secondary

Retinal Neovascularization on Clinical Exam

Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined.

Posted

Count of Participants

Participants

24 weeks

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Units

Secondary

Retinal Neovascularization on Clinical Exam

Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Units

Secondary

Retinal Neovascularization on Clinical Exam

Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
OG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Units

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Lymphangitis	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Bicuspid aortic valve	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Cardiac arrest	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0010 events0 affected105 at risk
Congestive heart failure	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events4 affected100 at risk EG0015 events4 affected105 at risk
Coronary artery disease	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Heart failure	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Mitral valve disorders	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Unstable angina	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Diabetes	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Diabetic ketoacidosis	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events4 affected100 at risk EG0013 events2 affected105 at risk
Hyperglycemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Hyperglycemic hyperosmolar nonketotic syndrome	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Hypoglycemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Loss of control of blood sugar	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Endophthalmitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Exposure keratoconjunctivitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Ischemia retinal	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Ocular fundus arteriosclerosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected100 at risk EG0010 events0 affected105 at risk
Traction retinal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Visual acuity decreased	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vitreous hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Appendicitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Bowel obstruction	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Gastritis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected100 at risk EG0010 events0 affected105 at risk
Gastroparesis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events1 affected100 at risk EG0010 events0 affected105 at risk
Hyperemesis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Chest pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Death	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Gait disturbance	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Leg edema	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Peripheral edema	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Acute cholecystitis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Anaphylaxis	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Abscess NOS	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Bacteremia	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Foot infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected100 at risk EG0011 events1 affected105 at risk
Infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Influenza	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
MRSA	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Sepsis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events5 affected100 at risk EG0010 events0 affected105 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Heart rate low	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Troponin increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Fluid overload - fluid volume increased	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Type II diabetes mellitus	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Water retention	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Back discomfort	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Broken bones	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Femur fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Fractured collar bone	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Fractured ribs	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hip fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events3 affected100 at risk EG0010 events0 affected105 at risk
Pulled hamstring	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Coma	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Viral meningitis	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Drug abuse	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0013 events2 affected105 at risk
Acute renal failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Chronic renal failure worsened	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events1 affected105 at risk
End stage renal disease (ESRD)	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Kidney failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected100 at risk EG0012 events1 affected105 at risk
Kidney infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Kidney stones	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Renal failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Urinary tract infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Testicular torsion	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Acute bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Cardiopulmonary arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Exacerbation of asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events1 affected105 at risk
Hypoxemia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0015 events4 affected105 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected100 at risk EG0010 events0 affected105 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Cellulitis of arm	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected100 at risk EG0010 events0 affected105 at risk
Cellulitis of foot	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Cellulitis of leg	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Cellulitis of toe	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Diabetic foot ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Foot ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Back surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Bypass surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Coronary artery bypass graft	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Foot surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Knee surgery NOS	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Metatarsal excision	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Stent placement	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Toe amputation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Embolism - blood clot	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Hypertension worsened	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected100 at risk EG0012 events2 affected105 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected100 at risk EG0011 events1 affected105 at risk
Intraventricular hemorrhage	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Ischemia - systemic	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Peripheral vascular disease	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Stroke	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Stroke (cerebrovascular accident)	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Stroke - Ischemic	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Transient ischemic attacks	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0018 events7 affected105 at risk
Anemia of chronic disease	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Anemia, unspecified	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Arteriosclerotic heart disease	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected105 at risk
Cardiomegaly	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Congestive heart failure	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Coronary artery disease	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Ischemic cardiomyopathy	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Myocardial disorder	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Pericardial effusion	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Pulmonary valve regurgitation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Tachycardia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Tricuspid regurgitation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Anomaly heart	Congenital, familial and genetic disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Ear infection	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Hearing loss	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Otitis externa	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Otitis media acute	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Diabetes	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Diabetes mellitus poor control	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Hyperglycemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hypoglycemia	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events5 affected100 at risk EG0013 events3 affected105 at risk
Hypothyroidism	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Loss of control of blood sugar	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0013 events3 affected105 at risk
Worsening of diabetes	Endocrine disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0012 events2 affected105 at risk
Allergic conjunctivitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Amaurosis fugax	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Anterior chamber angle neovascularisation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0011 events1 affected105 at risk
Anterior chamber cell	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0014 events3 affected105 at risk
Anterior chamber flare	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Atrophy of macula	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Band keratopathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Blepharitis (eyelid irritation)	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Blurred vision	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events9 affected100 at risk EG0013 events3 affected105 at risk
Blurry vision	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00011 events10 affected100 at risk EG0013 events3 affected105 at risk
Cataract	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00014 events14 affected100 at risk EG00123 events20 affected105 at risk
Cataract cortical	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected100 at risk EG0012 events1 affected105 at risk
Cataract fragments in eye postoperative	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Cataract subcapsular	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Chalazion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Choroidal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Cloudy vision	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0014 events4 affected105 at risk
Conjunctival cyst	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Conjunctival hyperemia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events1 affected105 at risk
Corneal abrasion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0012 events2 affected105 at risk
Corneal defect	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Corneal disorder (NOS)	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Corneal edema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0015 events5 affected105 at risk
Corneal endothelial disorder	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Corneal erosion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Corneal guttata	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Corneal haze	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Corneal irritation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Corneal scar	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Corneal ulcer	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Cortical spoking	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected100 at risk EG0012 events2 affected105 at risk
Cupping of optic nerve	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Decrease in depth perception	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Detachment of retinal pigment epithelium	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Diabetic macular edema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00011 events10 affected100 at risk EG00111 events9 affected105 at risk
Diplopia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Disc neovascularization	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected100 at risk EG0010 events0 affected105 at risk
Double vision	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Dry eye	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected100 at risk EG0017 events7 affected105 at risk
Dry eye syndrome	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Epiretinal membrane	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00013 events12 affected100 at risk EG00113 events13 affected105 at risk
Exposure keratoconjunctivitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Eye ache	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Eye irritation	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0015 events5 affected105 at risk
Eye itching	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events3 affected100 at risk EG0017 events7 affected105 at risk
Eye pain	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00014 events11 affected100 at risk EG0017 events6 affected105 at risk
Eye strain	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Eye tearing	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Eyelid edema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Eyelid pain	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Eyelid twitching	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Filmy vision	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Flame-shaped hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Floaters	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00030 events24 affected100 at risk EG00111 events11 affected105 at risk
Folds in Descemet's membrane	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Foreign body in conjunctival sac	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0014 events4 affected105 at risk
Glare	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Glaucoma	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0015 events4 affected105 at risk
Hazy vision	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0011 events1 affected105 at risk
Hordeolum	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Hypertensive retinopathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Hyphema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0015 events4 affected105 at risk
Hypotony of eye	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Intraretinal microvascular abnormalities	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events2 affected100 at risk EG0010 events0 affected105 at risk
Iris neovascularization	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Iritis (anterior uveitis, iridocyclitis)	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected100 at risk EG0011 events1 affected105 at risk
Ischemia retinal	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Keratopathy NOS	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Lattice degeneration of retina	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Macular atrophy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Macular dystrophy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Macular edema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Macular hole	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Macular puckering	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Macular scar	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Meibomian gland obstruction	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Neovascular glaucoma	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Neurosensory detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Nuclear sclerosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00016 events15 affected100 at risk EG00110 events10 affected105 at risk
Ocular discomfort	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Ocular hypertension	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0013 events3 affected105 at risk
Optic nerve pallor	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Photophobia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0011 events1 affected105 at risk
Photopsia	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Posterior capsule opacification	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00011 events10 affected100 at risk EG00112 events11 affected105 at risk
Posterior subcapsular cataract	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00019 events16 affected100 at risk EG00119 events16 affected105 at risk
Posterior vitreous detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Preretinal fibrosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Preretinal hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0010 events0 affected105 at risk
Proliferative vitreoretinopathy	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Ptosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Punctate epithelial erosion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0010 events0 affected105 at risk
Red eye	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected100 at risk EG0010 events0 affected105 at risk
Retinal cyst	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Retinal edema	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Retinal exudates	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events4 affected100 at risk EG0013 events3 affected105 at risk
Retinal hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Retinal macroaneurysm	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Retinal neovascularization	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0009 events7 affected100 at risk EG0013 events3 affected105 at risk
Retinal tear	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected100 at risk EG0015 events5 affected105 at risk
Retinal vessel avulsion	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Rubeosis iridis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected105 at risk
Secondary cataract	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Senile nuclear sclerosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Sensation of pressure in eye	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Sensitivity to light (photophobia)	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0014 events4 affected105 at risk
Soreness in eyes	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events3 affected100 at risk EG0010 events0 affected105 at risk
Stye	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Subconjunctival hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0014 events4 affected105 at risk
Subconjunctival/conjunctival hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Subretinal fibrosis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Subretinal hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Superficial punctate keratitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0012 events2 affected105 at risk
Swollen eyelid	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Swollen eyes	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Synechiae	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Traction retinal detachment	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00023 events20 affected100 at risk EG0013 events2 affected105 at risk
Varying retinal vessel calibre	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vision decreased	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00011 events11 affected100 at risk EG0016 events5 affected105 at risk
Vision peripheral decreased	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Visual acuity decreased	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected100 at risk EG0011 events1 affected105 at risk
Visual disturbances	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Visual flashes	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events3 affected100 at risk EG0015 events5 affected105 at risk
Vitreoretinal traction syndrome	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vitreous debris	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0010 events0 affected105 at risk
Vitreous disorder NOS	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vitreous floater	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Vitreous hemorrhage	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00075 events52 affected100 at risk EG00131 events24 affected105 at risk
Vitreous membranes and strands	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Vitreous opacities	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vitreous opacity	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Watering eyes	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0014 events3 affected105 at risk
Acid reflux (oesophageal)	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Barrett's esophagus	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Bloody stool	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Chipped tooth	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Constipation	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0014 events4 affected105 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events6 affected100 at risk EG0011 events1 affected105 at risk
Distention	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Duodenitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
External hemorrhoids	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Gastritis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Gastroesophageal reflux	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Gastroparesis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected100 at risk EG0017 events7 affected105 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Stomach pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected100 at risk EG0010 events0 affected105 at risk
Stomach virus	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Tooth abscess	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events1 affected100 at risk EG0010 events0 affected105 at risk
Tooth infection	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Toothache	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Upset stomach	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events6 affected100 at risk EG0012 events2 affected105 at risk
Anasarca	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Chest pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0011 events1 affected105 at risk
Chronic pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Cyst	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Dialysis access malfunction	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Fever	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
General Swelling	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Leg edema	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0011 events1 affected105 at risk
Localized superficial swelling, mass, or lump	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Pain NOS	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Pedal edema	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Swelling of feet	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Acute cholecystitis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Gallstones	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Hepatopathy	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Liver enlargement	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Allergic reaction	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Hives	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Seasonal allergy	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0011 events1 affected105 at risk
Specific allergy (drug)	Immune system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Abscess NOS	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Acute pharyngitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Bacteremia	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Diverticulitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Foot infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Fungal infection of nail	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Fungal skin infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Gum infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Infected toe	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0013 events2 affected105 at risk
Influenza	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00010 events10 affected100 at risk EG00110 events10 affected105 at risk
Lyme disease	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
MRSA	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Sepsis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Streptococcal infection NOS	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Thrush	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Viral syndrome	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Yeast infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Bee sting	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Black eye	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Bug bite	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Burn	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0009 events8 affected100 at risk EG0013 events3 affected105 at risk
Foot injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Knee injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events1 affected105 at risk
Laceration of leg	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Phlebitis - Injury	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Blood sugar decreased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Hormonal imbalance	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Intraocular pressure increased	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events7 affected100 at risk EG00110 events9 affected105 at risk
Laboratory test abnormal	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events1 affected105 at risk
Oxygen saturation low	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Potassium high	Investigations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Abnormal weight gain	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Fluid overload - fluid volume increased	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected100 at risk EG0010 events0 affected105 at risk
Hypercholesterolemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0013 events3 affected105 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0011 events1 affected105 at risk
Hyperlipidemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Hyperphosphatemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Hyperuricemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Magnesium deficiency	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Morbid obesity	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vitamin B6 deficiency	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Water retention	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Ankle fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Arthritis NOS	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Back discomfort	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected100 at risk EG0012 events2 affected105 at risk
Back strain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Bone spur	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Broken bones	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Broken foot	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Charcot arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Degenerative disc disease	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Dislocated shoulder	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Foot fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Foot pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected100 at risk EG0010 events0 affected105 at risk
Fractured ribs	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Frozen shoulder	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Gout	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0013 events3 affected105 at risk
Hand pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hip fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Intervertebral disc bulging	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Knee pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0011 events1 affected105 at risk
Leg pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Muscle cramps	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected100 at risk EG0010 events0 affected105 at risk
Muscle pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0012 events2 affected105 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Pain in arm	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Pain in hip	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Sprained ankle	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Sprains and strains of ribs	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Wrist fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Wrist pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Bell's palsy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Concussion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0012 events2 affected105 at risk
Head pain	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Head pressure	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0009 events9 affected100 at risk EG0017 events7 affected105 at risk
Migraine headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected100 at risk EG0010 events0 affected105 at risk
Neuropathy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0010 events0 affected105 at risk
Numbness in hand	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Paralysis	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Restless leg syndrome	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Sciatica	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Seizures	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
VIth nerve palsy	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Vertigo	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0014 events4 affected105 at risk
Deposit on the surface of intraocular lens	Product Issues	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Adjustment disorder NOS	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0011 events1 affected105 at risk
Depression	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0013 events3 affected105 at risk
Insomnia	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Acute renal failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Bladder infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events2 affected100 at risk EG0017 events7 affected105 at risk
Chronic renal failure worsened	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
End stage renal disease (ESRD)	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Kidney failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Kidney function abnormal	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Kidney infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Kidney stones	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0010 events0 affected105 at risk
Nocturia	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Proteinuria	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Pyelonephritis	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Renal failure	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Renal insufficiency	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Uremia	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Urinary hesitancy	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Urinary tract infection	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00013 events8 affected100 at risk EG0019 events7 affected105 at risk
Enlarged prostate	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Hydrocele	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Uterine bleeding	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Uterine fibroid	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Vulvodynia	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Acute bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0010 events0 affected105 at risk
Acute sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0011 events1 affected105 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected100 at risk EG0011 events1 affected105 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Chest congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Cold	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00017 events13 affected100 at risk EG0019 events7 affected105 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Hypoxemia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected105 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected105 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0009 events9 affected100 at risk EG0014 events4 affected105 at risk
Sinus infection	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0011 events1 affected105 at risk
Sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0013 events3 affected105 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events3 affected100 at risk EG0014 events3 affected105 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Blister of foot and toe(s), without mention of infection	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Bruise	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Cellulitis of foot	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Cellulitis of toe	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Dermatochalasis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected105 at risk
Diabetic foot ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events1 affected105 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Epidermal cyst	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Erythematous conditions	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Foot ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events2 affected100 at risk EG0015 events3 affected105 at risk
Fungal infection of nail	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Itching	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Mole of skin	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Sebaceous cyst	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Skin abrasion	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Skin cancer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Skin infection	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0010 events0 affected105 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Swelling of face	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Benign tumor excision	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk
Carpal tunnel release	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Cataract extraction	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Coronary stent placement	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Foot surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Sinus operation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Skin graft	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG00018 events1 affected100 at risk EG0010 events0 affected105 at risk
Surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0012 events2 affected105 at risk
Toe amputation	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected105 at risk
Tooth extraction	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0013 events3 affected105 at risk
Vitrectomy	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Wrist surgery	Surgical and medical procedures	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Arteriovenous graft site hemorrhage	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Benign essential hypertension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected100 at risk EG0014 events4 affected105 at risk
Hypertension worsened	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events6 affected100 at risk EG0013 events3 affected105 at risk
Hypertensive crisis	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected105 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected100 at risk EG0011 events1 affected105 at risk
Iliac artery blockage	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Peripheral arterial disease	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected105 at risk
Stroke	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected105 at risk
Venous malformation NOS	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected105 at risk

ID	Term
D005130	Eye Hemorrhage
D005128	Eye Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
BG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser
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	Intravitreous 2 mg Aflibercept Injections	Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. 2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.	6	100	44	100	97	100
EG001	Prompt Vitrectomy Plus Panretinal Photocoagulation	For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser	3	105	45	105	98	105