Trial Outcomes & Findings for Anti-VEGF vs. Prompt Vitrectomy for VH From PDR (NCT NCT02858076)
NCT ID: NCT02858076
Last Updated: 2021-04-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
205 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-04-20
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
105
|
|
Overall Study
COMPLETED
|
90
|
87
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Death
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
|
Overall Study
Completed Out of Window
|
1
|
3
|
Baseline Characteristics
Hemoglobin A1c was missing for 4 and 1 eye(s) in the Intravitreous 2 mg aflibercept injections and Prompt vitrectomy plus panretinal photocoagulation groups, respectively.
Baseline characteristics by cohort
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=100 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=105 Participants
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
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 12 • n=100 Participants
|
57 years
STANDARD_DEVIATION 11 • n=105 Participants
|
57 years
STANDARD_DEVIATION 11 • n=205 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=100 Participants
|
43 Participants
n=105 Participants
|
90 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=100 Participants
|
62 Participants
n=105 Participants
|
115 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
43 Participants
n=100 Participants
|
41 Participants
n=105 Participants
|
84 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
36 Participants
n=100 Participants
|
47 Participants
n=105 Participants
|
83 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black/African American
|
16 Participants
n=100 Participants
|
11 Participants
n=105 Participants
|
27 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=100 Participants
|
5 Participants
n=105 Participants
|
7 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=100 Participants
|
0 Participants
n=105 Participants
|
1 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=100 Participants
|
0 Participants
n=105 Participants
|
1 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
1 Participants
n=100 Participants
|
1 Participants
n=105 Participants
|
2 Participants
n=205 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=100 Participants
|
105 participants
n=105 Participants
|
205 participants
n=205 Participants
|
|
Diabetes Type
Type 1
|
17 Participants
n=100 Participants
|
19 Participants
n=105 Participants
|
36 Participants
n=205 Participants
|
|
Diabetes Type
Type 2
|
83 Participants
n=100 Participants
|
86 Participants
n=105 Participants
|
169 Participants
n=205 Participants
|
|
Duration of Diabetes
|
19 years
STANDARD_DEVIATION 10 • n=100 Participants
|
21 years
STANDARD_DEVIATION 11 • n=105 Participants
|
20 years
STANDARD_DEVIATION 11 • n=205 Participants
|
|
Insulin Used
Yes
|
78 Participants
n=100 Participants
|
78 Participants
n=105 Participants
|
156 Participants
n=205 Participants
|
|
Insulin Used
No
|
22 Participants
n=100 Participants
|
27 Participants
n=105 Participants
|
49 Participants
n=205 Participants
|
|
Hemoglobin A1c
|
8.7 Hemoglobin A1c percentage
STANDARD_DEVIATION 2.2 • n=96 Participants • Hemoglobin A1c was missing for 4 and 1 eye(s) in the Intravitreous 2 mg aflibercept injections and Prompt vitrectomy plus panretinal photocoagulation groups, respectively.
|
8.3 Hemoglobin A1c percentage
STANDARD_DEVIATION 1.9 • n=104 Participants • Hemoglobin A1c was missing for 4 and 1 eye(s) in the Intravitreous 2 mg aflibercept injections and Prompt vitrectomy plus panretinal photocoagulation groups, respectively.
|
8.5 Hemoglobin A1c percentage
STANDARD_DEVIATION 2.0 • n=200 Participants • Hemoglobin A1c was missing for 4 and 1 eye(s) in the Intravitreous 2 mg aflibercept injections and Prompt vitrectomy plus panretinal photocoagulation groups, respectively.
|
|
Mean Arterial Blood Pressure
|
102 mmHg
STANDARD_DEVIATION 12 • n=100 Participants
|
102 mmHg
STANDARD_DEVIATION 12 • n=105 Participants
|
102 mmHg
STANDARD_DEVIATION 12 • n=205 Participants
|
|
Prior Myocardial Infarction
|
7 Participants
n=100 Participants
|
15 Participants
n=105 Participants
|
22 Participants
n=205 Participants
|
|
Prior Stroke
|
5 Participants
n=100 Participants
|
8 Participants
n=105 Participants
|
13 Participants
n=205 Participants
|
|
Kidney Disease
|
20 Participants
n=100 Participants
|
18 Participants
n=105 Participants
|
38 Participants
n=205 Participants
|
|
Body Mass Index
|
31 kg/m^2
STANDARD_DEVIATION 7 • n=85 Participants • 15 and 12 were missing for the Aflibercept and Sham groups, respectively.
|
32 kg/m^2
STANDARD_DEVIATION 7 • n=93 Participants • 15 and 12 were missing for the Aflibercept and Sham groups, respectively.
|
31 kg/m^2
STANDARD_DEVIATION 7 • n=178 Participants • 15 and 12 were missing for the Aflibercept and Sham groups, respectively.
|
|
Daily Cigarette Smoking
Never
|
60 Participants
n=100 Participants
|
72 Participants
n=105 Participants
|
132 Participants
n=205 Participants
|
|
Daily Cigarette Smoking
Prior
|
27 Participants
n=100 Participants
|
25 Participants
n=105 Participants
|
52 Participants
n=205 Participants
|
|
Daily Cigarette Smoking
Current
|
13 Participants
n=100 Participants
|
8 Participants
n=105 Participants
|
21 Participants
n=205 Participants
|
|
Prior Treatment for Diabetic Macular Edema
|
29 Eyes
n=100 Participants
|
37 Eyes
n=105 Participants
|
66 Eyes
n=205 Participants
|
|
Prior anti-vascular endothelial growth factor for diabetic macular edema
|
23 Eyes
n=100 Participants
|
28 Eyes
n=105 Participants
|
51 Eyes
n=205 Participants
|
|
Prior anti-vascular endothelial growth factor for diabetic retinopathy
|
23 Eyes
n=100 Participants
|
22 Eyes
n=105 Participants
|
45 Eyes
n=205 Participants
|
|
Prior panretinal photocoagulation
|
42 Eyes
n=100 Participants
|
58 Eyes
n=105 Participants
|
100 Eyes
n=205 Participants
|
|
Approximate Duration of Vitreous Hemorrhage
Less than 1 Month
|
60 Eyes
n=100 Participants
|
57 Eyes
n=105 Participants
|
117 Eyes
n=205 Participants
|
|
Approximate Duration of Vitreous Hemorrhage
1 to 3 Months
|
27 Eyes
n=100 Participants
|
27 Eyes
n=105 Participants
|
54 Eyes
n=205 Participants
|
|
Approximate Duration of Vitreous Hemorrhage
4 to 6 Months
|
8 Eyes
n=100 Participants
|
6 Eyes
n=105 Participants
|
14 Eyes
n=205 Participants
|
|
Approximate Duration of Vitreous Hemorrhage
7 to 12 Months
|
1 Eyes
n=100 Participants
|
6 Eyes
n=105 Participants
|
7 Eyes
n=205 Participants
|
|
Approximate Duration of Vitreous Hemorrhage
More than 12 Months
|
4 Eyes
n=100 Participants
|
9 Eyes
n=105 Participants
|
13 Eyes
n=205 Participants
|
|
Lens Status on Clinical Exam
Phakic (natural lens)
|
75 Eyes
n=100 Participants
|
81 Eyes
n=105 Participants
|
156 Eyes
n=205 Participants
|
|
Lens Status on Clinical Exam
Prosthetic intraocular lens
|
25 Eyes
n=100 Participants
|
24 Eyes
n=105 Participants
|
49 Eyes
n=205 Participants
|
|
E-ETDRS visual acuity letter score
|
35.6 units on a scale
STANDARD_DEVIATION 28.1 • n=100 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 28.8 • n=105 Participants
|
34.5 units on a scale
STANDARD_DEVIATION 28.4 • n=205 Participants
|
|
Traction Retinal Detachment, Macula Not Threatened
|
5 Eyes
n=100 Participants
|
3 Eyes
n=105 Participants
|
8 Eyes
n=205 Participants
|
|
Intraocular Pressure
|
16 mmHg
STANDARD_DEVIATION 4 • n=100 Participants
|
15 mmHg
STANDARD_DEVIATION 3 • n=105 Participants
|
15 mmHg
STANDARD_DEVIATION 4 • n=205 Participants
|
|
Prior focal/grid laser for Diabetic Macular Edema
|
15 Eyes
n=100 Participants
|
16 Eyes
n=105 Participants
|
31 Eyes
n=205 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe 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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=97 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=98 Participants
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
|
|---|---|---|
|
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
|
59.3 units on a scale
Standard Deviation 21.9
|
63.0 units on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 4 WeeksBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=95 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=99 Participants
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
|
|---|---|---|
|
E-ETDRS Visual Acuity Letter Score
|
52.6 units on a scale
Standard Deviation 29.4
|
62.3 units on a scale
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: 12 WeeksBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=97 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=102 Participants
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
|
|---|---|---|
|
E-ETDRS Visual Acuity Letter Score
|
63.7 units on a scale
Standard Deviation 25.0
|
67.3 units on a scale
Standard Deviation 24.7
|
SECONDARY outcome
Timeframe: 24 WeeksBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=97 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=98 Participants
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
|
|---|---|---|
|
E-ETDRS Visual Acuity Letter Score
|
69.4 units on a scale
Standard Deviation 23.8
|
69.0 units on a scale
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: 1-Year from participant randomizationBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=95 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=98 Participants
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
|
|---|---|---|
|
E-ETDRS Visual Acuity Letter Score
|
70.5 units on a scale
Standard Deviation 20.3
|
72.7 units on a scale
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: 2 YearsBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=90 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=87 Participants
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
|
|---|---|---|
|
E-ETDRS Visual Acuity Letter Score
|
73.7 units on a scale
Standard Deviation 16.4
|
71.0 units on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: 2-YearsBest-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. 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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=90 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=87 Participants
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
|
|---|---|---|
|
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
|
68.7 units on a scale
Standard Deviation 15.0
|
70.0 units on a scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: 4 weeksBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=95 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=99 Participants
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
|
|---|---|---|
|
Snellen Equivalent Range (Visual Acuity Score)
20/32 or better (>=74)
|
24 Participants
|
49 Participants
|
|
Snellen Equivalent Range (Visual Acuity Score)
20/200 or worse (<=38)
|
26 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 12 weeksBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=97 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=102 Participants
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
|
|---|---|---|
|
Snellen Equivalent Range (Visual Acuity Score)
20/32 or better (>=74
|
45 Participants
|
58 Participants
|
|
Snellen Equivalent Range (Visual Acuity Score)
20/200 or worse (<=38)
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 weeksBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=97 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=98 Participants
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
|
|---|---|---|
|
Snellen Equivalent Range (Visual Acuity Score)
20/32 or better (>=74
|
61 Participants
|
59 Participants
|
|
Snellen Equivalent Range (Visual Acuity Score)
20/200 or worse (<=38)
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearBest-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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=95 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=98 Participants
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
|
|---|---|---|
|
Snellen Equivalent Range (Visual Acuity Score)
20/32 or better (>=74
|
55 Participants
|
65 Participants
|
|
Snellen Equivalent Range (Visual Acuity Score)
20/200 or worse (<=38)
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 yearsBest-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..
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=90 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=87 Participants
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
|
|---|---|---|
|
Snellen Equivalent Range (Visual Acuity Score)
20/200 or worse (<=38)
|
3 Participants
|
10 Participants
|
|
Snellen Equivalent Range (Visual Acuity Score)
20/32 or better (>=74
|
56 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: At any time through 2 yearsAssessed 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.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=97 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=104 Participants
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
|
|---|---|---|
|
Recurrent Vitreous Hemorrhage
|
48 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 24 weeksDefined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined.
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=85 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=92 Participants
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
|
|---|---|---|
|
Retinal Neovascularization on Clinical Exam
|
25 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearDefined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=89 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=95 Participants
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
|
|---|---|---|
|
Retinal Neovascularization on Clinical Exam
|
15 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsDefined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined
Outcome measures
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=88 Participants
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=83 Participants
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
|
|---|---|---|
|
Retinal Neovascularization on Clinical Exam
|
20 Participants
|
2 Participants
|
Adverse Events
Intravitreous 2 mg Aflibercept Injections
Serious events: 44 serious events
Other events: 97 other events
Deaths: 6 deaths
Prompt Vitrectomy Plus Panretinal Photocoagulation
Serious events: 45 serious events
Other events: 98 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=100 participants at risk
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=105 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Blood and lymphatic system disorders
Lymphangitis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Acute coronary syndrome
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Bicuspid aortic valve
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Cardiac arrest
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Congestive heart failure
|
4.0%
4/100 • Number of events 6 • 2 Years
|
3.8%
4/105 • Number of events 5 • 2 Years
|
|
Cardiac disorders
Coronary artery disease
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Cardiac disorders
Heart failure
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Cardiac disorders
Mitral valve disorders
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Unstable angina
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Endocrine disorders
Diabetes
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Diabetic ketoacidosis
|
4.0%
4/100 • Number of events 7 • 2 Years
|
1.9%
2/105 • Number of events 3 • 2 Years
|
|
Endocrine disorders
Hyperglycemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Endocrine disorders
Hyperglycemic hyperosmolar nonketotic syndrome
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Endocrine disorders
Hypoglycemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Loss of control of blood sugar
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Endophthalmitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Exposure keratoconjunctivitis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Ischemia retinal
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Ocular fundus arteriosclerosis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
2.0%
2/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Traction retinal detachment
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Visual acuity decreased
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Vitreous hemorrhage
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Appendicitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.0%
3/100 • Number of events 4 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Gastroparesis
|
1.0%
1/100 • Number of events 4 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Hyperemesis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Chest pain
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Death
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Gait disturbance
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
General disorders
Leg edema
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Peripheral edema
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Immune system disorders
Anaphylaxis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Abscess NOS
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Infections and infestations
Bacteremia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Foot infection
|
6.0%
6/100 • Number of events 6 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Infection
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Influenza
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
MRSA
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Sepsis
|
5.0%
5/100 • Number of events 6 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Head injury
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Investigations
Heart rate low
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Investigations
Troponin increased
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Fluid overload - fluid volume increased
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Type II diabetes mellitus
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Water retention
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back discomfort
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Broken bones
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Fractured collar bone
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Fractured ribs
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
3.0%
3/100 • Number of events 6 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pulled hamstring
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Coma
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Syncope
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Viral meningitis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Psychiatric disorders
Drug abuse
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 3 • 2 Years
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Chronic renal failure worsened
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
End stage renal disease (ESRD)
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Kidney failure
|
7.0%
7/100 • Number of events 7 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Kidney infection
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Renal failure
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Urinary tract infection
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cardiopulmonary arrest
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.0%
3/100 • Number of events 3 • 2 Years
|
3.8%
4/105 • Number of events 5 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.0%
2/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis of arm
|
1.0%
1/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis of foot
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis of leg
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis of toe
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Diabetic foot ulcer
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Foot ulcer
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Back surgery
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Bypass surgery
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Coronary artery bypass graft
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Foot surgery
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Knee surgery NOS
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Metatarsal excision
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Embolism - blood clot
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Vascular disorders
Hypertension
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Vascular disorders
Hypertension worsened
|
3.0%
3/100 • Number of events 4 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Vascular disorders
Hypotension
|
2.0%
2/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Intraventricular hemorrhage
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Ischemia - systemic
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Peripheral vascular disease
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Vascular disorders
Stroke
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Stroke (cerebrovascular accident)
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Stroke - Ischemic
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Vascular disorders
Transient ischemic attacks
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
Other adverse events
| Measure |
Intravitreous 2 mg Aflibercept Injections
n=100 participants at risk
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.
|
Prompt Vitrectomy Plus Panretinal Photocoagulation
n=105 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Eye injury
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
8/100 • Number of events 9 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
General disorders
Localized superficial swelling, mass, or lump
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Pain NOS
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Pedal edema
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
General disorders
Swelling of feet
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Hepatobiliary disorders
Gallstones
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Hepatobiliary disorders
Hepatopathy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Hepatobiliary disorders
Liver enlargement
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Immune system disorders
Allergic reaction
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Immune system disorders
Hives
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Immune system disorders
Seasonal allergy
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Immune system disorders
Specific allergy (drug)
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Abscess NOS
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Acute pharyngitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Bacteremia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Diverticulitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Foot infection
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Infections and infestations
Fungal infection of nail
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Infections and infestations
Gum infection
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Infected toe
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Infection
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 3 • 2 Years
|
|
Infections and infestations
Influenza
|
10.0%
10/100 • Number of events 10 • 2 Years
|
9.5%
10/105 • Number of events 10 • 2 Years
|
|
Infections and infestations
Lyme disease
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
MRSA
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Sepsis
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Infections and infestations
Streptococcal infection NOS
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Thrush
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Infections and infestations
Viral syndrome
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Infections and infestations
Yeast infection
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Injury, poisoning and procedural complications
Back injury
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
4/100 • Number of events 4 • 2 Years
|
6.7%
7/105 • Number of events 8 • 2 Years
|
|
Blood and lymphatic system disorders
Anemia of chronic disease
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Anemia, unspecified
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Arteriosclerotic heart disease
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/100 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Congestive heart failure
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Left ventricular hypertrophy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Myocardial disorder
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Pericardial effusion
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Pulmonary valve regurgitation
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Tricuspid regurgitation
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Congenital, familial and genetic disorders
Anomaly heart
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Ear and labyrinth disorders
Otitis media acute
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Endocrine disorders
Diabetes
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Diabetes mellitus poor control
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Hyperglycemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Hypoglycemia
|
5.0%
5/100 • Number of events 6 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Endocrine disorders
Loss of control of blood sugar
|
1.0%
1/100 • Number of events 1 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Endocrine disorders
Worsening of diabetes
|
3.0%
3/100 • Number of events 3 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Allergic conjunctivitis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Amaurosis fugax
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Anterior chamber angle neovascularisation
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Anterior chamber cell
|
4.0%
4/100 • Number of events 4 • 2 Years
|
2.9%
3/105 • Number of events 4 • 2 Years
|
|
Eye disorders
Anterior chamber flare
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Atrophy of macula
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Band keratopathy
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Blepharitis (eyelid irritation)
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Blurred vision
|
9.0%
9/100 • Number of events 10 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Eye disorders
Blurry vision
|
10.0%
10/100 • Number of events 11 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Eye disorders
Cataract
|
14.0%
14/100 • Number of events 14 • 2 Years
|
19.0%
20/105 • Number of events 23 • 2 Years
|
|
Eye disorders
Cataract cortical
|
5.0%
5/100 • Number of events 5 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Cataract fragments in eye postoperative
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Cataract subcapsular
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Chalazion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Choroidal detachment
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Cloudy vision
|
0.00%
0/100 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Eye disorders
Conjunctival cyst
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Conjunctival hyperemia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Corneal abrasion
|
3.0%
3/100 • Number of events 3 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Corneal defect
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal disorder (NOS)
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal edema
|
0.00%
0/100 • 2 Years
|
4.8%
5/105 • Number of events 5 • 2 Years
|
|
Eye disorders
Corneal endothelial disorder
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Corneal erosion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal guttata
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal haze
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal irritation
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Corneal scar
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Cortical spoking
|
7.0%
7/100 • Number of events 7 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Cupping of optic nerve
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Decrease in depth perception
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Diabetic macular edema
|
10.0%
10/100 • Number of events 11 • 2 Years
|
8.6%
9/105 • Number of events 11 • 2 Years
|
|
Eye disorders
Diplopia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Disc neovascularization
|
7.0%
7/100 • Number of events 7 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Double vision
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Dry eye
|
6.0%
6/100 • Number of events 6 • 2 Years
|
6.7%
7/105 • Number of events 7 • 2 Years
|
|
Eye disorders
Dry eye syndrome
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Epiretinal membrane
|
12.0%
12/100 • Number of events 13 • 2 Years
|
12.4%
13/105 • Number of events 13 • 2 Years
|
|
Eye disorders
Exposure keratoconjunctivitis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Eye ache
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Eye irritation
|
2.0%
2/100 • Number of events 2 • 2 Years
|
4.8%
5/105 • Number of events 5 • 2 Years
|
|
Eye disorders
Eye itching
|
3.0%
3/100 • Number of events 5 • 2 Years
|
6.7%
7/105 • Number of events 7 • 2 Years
|
|
Eye disorders
Eye pain
|
11.0%
11/100 • Number of events 14 • 2 Years
|
5.7%
6/105 • Number of events 7 • 2 Years
|
|
Eye disorders
Eye strain
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Eye tearing
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Eyelid edema
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Eyelid pain
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Eyelid twitching
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Filmy vision
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Flame-shaped hemorrhage
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Floaters
|
24.0%
24/100 • Number of events 30 • 2 Years
|
10.5%
11/105 • Number of events 11 • 2 Years
|
|
Eye disorders
Folds in Descemet's membrane
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Foreign body in conjunctival sac
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Foreign body sensation in eyes
|
2.0%
2/100 • Number of events 2 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Eye disorders
Glare
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Glaucoma
|
2.0%
2/100 • Number of events 2 • 2 Years
|
3.8%
4/105 • Number of events 5 • 2 Years
|
|
Eye disorders
Hazy vision
|
4.0%
4/100 • Number of events 4 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Hordeolum
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Hypertensive retinopathy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Hyphema
|
0.00%
0/100 • 2 Years
|
3.8%
4/105 • Number of events 5 • 2 Years
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Intraretinal microvascular abnormalities
|
2.0%
2/100 • Number of events 4 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Iris neovascularization
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Iritis (anterior uveitis, iridocyclitis)
|
1.0%
1/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Ischemia retinal
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Keratopathy NOS
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Lattice degeneration of retina
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Macular atrophy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Macular dystrophy
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Macular edema
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Macular hole
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Macular puckering
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Macular scar
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Meibomian gland obstruction
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Neovascular glaucoma
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Neurosensory detachment
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Nuclear sclerosis
|
15.0%
15/100 • Number of events 16 • 2 Years
|
9.5%
10/105 • Number of events 10 • 2 Years
|
|
Eye disorders
Ocular discomfort
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Ocular hypertension
|
3.0%
3/100 • Number of events 3 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Eye disorders
Optic nerve pallor
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Photophobia
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Photopsia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Posterior capsule opacification
|
10.0%
10/100 • Number of events 11 • 2 Years
|
10.5%
11/105 • Number of events 12 • 2 Years
|
|
Eye disorders
Posterior subcapsular cataract
|
16.0%
16/100 • Number of events 19 • 2 Years
|
15.2%
16/105 • Number of events 19 • 2 Years
|
|
Eye disorders
Posterior vitreous detachment
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Preretinal fibrosis
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Preretinal hemorrhage
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Proliferative vitreoretinopathy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Ptosis
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Punctate epithelial erosion
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Red eye
|
1.0%
1/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Retinal cyst
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Retinal edema
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Retinal exudates
|
4.0%
4/100 • Number of events 5 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Eye disorders
Retinal hemorrhage
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Retinal macroaneurysm
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Retinal neovascularization
|
7.0%
7/100 • Number of events 9 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Eye disorders
Retinal tear
|
7.0%
7/100 • Number of events 7 • 2 Years
|
4.8%
5/105 • Number of events 5 • 2 Years
|
|
Eye disorders
Retinal vessel avulsion
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Rubeosis iridis
|
0.00%
0/100 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Eye disorders
Secondary cataract
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Senile nuclear sclerosis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Sensation of pressure in eye
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Sensitivity to light (photophobia)
|
2.0%
2/100 • Number of events 2 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Eye disorders
Soreness in eyes
|
3.0%
3/100 • Number of events 5 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Stye
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Subconjunctival hemorrhage
|
3.0%
3/100 • Number of events 3 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Eye disorders
Subconjunctival/conjunctival hemorrhage
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Subretinal fibrosis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Subretinal hemorrhage
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Superficial punctate keratitis
|
3.0%
3/100 • Number of events 3 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Eye disorders
Swollen eyelid
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Swollen eyes
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Synechiae
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Traction retinal detachment
|
20.0%
20/100 • Number of events 23 • 2 Years
|
1.9%
2/105 • Number of events 3 • 2 Years
|
|
Eye disorders
Varying retinal vessel calibre
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Vision decreased
|
11.0%
11/100 • Number of events 11 • 2 Years
|
4.8%
5/105 • Number of events 6 • 2 Years
|
|
Eye disorders
Vision peripheral decreased
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Visual acuity decreased
|
3.0%
3/100 • Number of events 4 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Visual disturbances
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Visual flashes
|
3.0%
3/100 • Number of events 5 • 2 Years
|
4.8%
5/105 • Number of events 5 • 2 Years
|
|
Eye disorders
Vitreoretinal traction syndrome
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Vitreous debris
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Vitreous disorder NOS
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Vitreous floater
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Vitreous hemorrhage
|
52.0%
52/100 • Number of events 75 • 2 Years
|
22.9%
24/105 • Number of events 31 • 2 Years
|
|
Eye disorders
Vitreous membranes and strands
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Eye disorders
Vitreous opacities
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Vitreous opacity
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Eye disorders
Watering eyes
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
3/100 • Number of events 3 • 2 Years
|
2.9%
3/105 • Number of events 4 • 2 Years
|
|
Gastrointestinal disorders
Acid reflux (oesophageal)
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Barrett's esophagus
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Bloody stool
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Chipped tooth
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Constipation
|
3.0%
3/100 • Number of events 3 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Gastrointestinal disorders
Diarrhea
|
6.0%
6/100 • Number of events 8 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Distention
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Duodenitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
External hemorrhoids
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Gastroparesis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
5.0%
5/100 • Number of events 5 • 2 Years
|
6.7%
7/105 • Number of events 7 • 2 Years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Peritonitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Stomach pain
|
1.0%
1/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Stomach virus
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Tooth abscess
|
1.0%
1/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Injury, poisoning and procedural complications
Bee sting
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Tooth infection
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Injury, poisoning and procedural complications
Black eye
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Bug bite
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Upset stomach
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
6/100 • Number of events 8 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
General disorders
Anasarca
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
General disorders
Chest pain
|
4.0%
4/100 • Number of events 4 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Chronic pain
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Cyst
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Dialysis access malfunction
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Fever
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
General Swelling
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
General disorders
Leg edema
|
4.0%
4/100 • Number of events 4 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Foot injury
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Knee injury
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Injury, poisoning and procedural complications
Laceration of leg
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Phlebitis - Injury
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Injury, poisoning and procedural complications
Wound
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Investigations
Blood sugar decreased
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Investigations
Hormonal imbalance
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Investigations
Intraocular pressure increased
|
7.0%
7/100 • Number of events 7 • 2 Years
|
8.6%
9/105 • Number of events 10 • 2 Years
|
|
Investigations
Laboratory test abnormal
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Investigations
Oxygen saturation low
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Investigations
Potassium high
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Fluid overload - fluid volume increased
|
2.0%
2/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
4.0%
4/100 • Number of events 4 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Morbid obesity
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Vitamin B6 deficiency
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Metabolism and nutrition disorders
Water retention
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthritis NOS
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back discomfort
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
5/100 • Number of events 5 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back strain
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Bone spur
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Broken bones
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Broken foot
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Charcot arthropathy
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Degenerative disc disease
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Dislocated shoulder
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
1.0%
1/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Fractured ribs
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Frozen shoulder
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Gout
|
1.0%
1/100 • Number of events 1 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Hand pain
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc bulging
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
4.0%
4/100 • Number of events 4 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
2.0%
2/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
3.0%
3/100 • Number of events 3 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in arm
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Sprained ankle
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Sprains and strains of ribs
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Wrist pain
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Concussion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Diabetic neuropathy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Dizziness
|
4.0%
4/100 • Number of events 4 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Head pain
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Head pressure
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Headache
|
9.0%
9/100 • Number of events 9 • 2 Years
|
6.7%
7/105 • Number of events 7 • 2 Years
|
|
Nervous system disorders
Migraine headache
|
3.0%
3/100 • Number of events 4 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Neuropathy
|
4.0%
4/100 • Number of events 4 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Numbness in hand
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Paralysis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Restless leg syndrome
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Sciatica
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Seizures
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
Syncope
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Nervous system disorders
VIth nerve palsy
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Vertigo
|
1.0%
1/100 • Number of events 1 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Product Issues
Deposit on the surface of intraocular lens
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Psychiatric disorders
Adjustment disorder NOS
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Psychiatric disorders
Anxiety
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Psychiatric disorders
Depression
|
2.0%
2/100 • Number of events 2 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Acute renal failure
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Bladder infection
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
2/100 • Number of events 4 • 2 Years
|
6.7%
7/105 • Number of events 7 • 2 Years
|
|
Renal and urinary disorders
Chronic renal failure worsened
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
End stage renal disease (ESRD)
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Kidney failure
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Kidney function abnormal
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Kidney infection
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Kidney stones
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Nocturia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Uremia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Urinary tract infection
|
8.0%
8/100 • Number of events 13 • 2 Years
|
6.7%
7/105 • Number of events 9 • 2 Years
|
|
Reproductive system and breast disorders
Enlarged prostate
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Hydrocele
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Uterine bleeding
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Reproductive system and breast disorders
Uterine fibroid
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Reproductive system and breast disorders
Vulvodynia
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.0%
6/100 • Number of events 6 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
13.0%
13/100 • Number of events 17 • 2 Years
|
6.7%
7/105 • Number of events 9 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/100 • Number of events 1 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
9.0%
9/100 • Number of events 9 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
4.0%
4/100 • Number of events 4 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.0%
3/100 • Number of events 4 • 2 Years
|
2.9%
3/105 • Number of events 4 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Blister of foot and toe(s), without mention of infection
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Bruise
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis of foot
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis of toe
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dermatochalasis
|
0.00%
0/100 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Diabetic foot ulcer
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 2 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Epidermal cyst
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Erythematous conditions
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Foot ulcer
|
2.0%
2/100 • Number of events 3 • 2 Years
|
2.9%
3/105 • Number of events 5 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Fungal infection of nail
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Mole of skin
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Sebaceous cyst
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin cancer
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Swelling of face
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Benign tumor excision
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Carpal tunnel release
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Cataract extraction
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Coronary stent placement
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Foot surgery
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Sinus operation
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Skin graft
|
1.0%
1/100 • Number of events 18 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Surgery
|
2.0%
2/100 • Number of events 2 • 2 Years
|
1.9%
2/105 • Number of events 2 • 2 Years
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/100 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Surgical and medical procedures
Tooth extraction
|
3.0%
3/100 • Number of events 3 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Surgical and medical procedures
Vitrectomy
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Surgical and medical procedures
Wrist surgery
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Arteriovenous graft site hemorrhage
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Benign essential hypertension
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Vascular disorders
Hypertension
|
4.0%
4/100 • Number of events 4 • 2 Years
|
3.8%
4/105 • Number of events 4 • 2 Years
|
|
Vascular disorders
Hypertension worsened
|
6.0%
6/100 • Number of events 7 • 2 Years
|
2.9%
3/105 • Number of events 3 • 2 Years
|
|
Vascular disorders
Hypertensive crisis
|
2.0%
2/100 • Number of events 2 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Hypotension
|
3.0%
3/100 • Number of events 3 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Iliac artery blockage
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Peripheral arterial disease
|
0.00%
0/100 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
|
Vascular disorders
Stroke
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.00%
0/105 • 2 Years
|
|
Vascular disorders
Venous malformation NOS
|
1.0%
1/100 • Number of events 1 • 2 Years
|
0.95%
1/105 • Number of events 1 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place