Trial Outcomes & Findings for Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye (NCT NCT02581891)
NCT ID: NCT02581891
Last Updated: 2023-11-08
Results Overview
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
287 participants
Primary outcome timeframe
From Week 16 to Week 104
Results posted on
2023-11-08
Participant Flow
This study was conducted from 19-Nov-2015 (First Patient First Visit) to 26-Apr-2019 (Last Patient Last Visit).
A total of 443 participants were screened in this study. Of these, 156 participants were screening failures and did not enter the treatment period. Of the 287 treated participants, 16 were treated during the initiation phase, but were not randomized to a treatment arm after the initiation phase.
Participant milestones
| Measure |
Early-start T&E Arm
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
136
|
|
Overall Study
Completed Treatment
|
120
|
117
|
|
Overall Study
COMPLETED
|
119
|
117
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Early-start T&E Arm
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Other Reasons
|
3
|
1
|
|
Overall Study
Discontinued during followup
|
1
|
0
|
Baseline Characteristics
PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
Baseline characteristics by cohort
| Measure |
Early-start T&E Arm
n=135 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=136 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 Years
STANDARD_DEVIATION 8.8 • n=135 Participants
|
76.9 Years
STANDARD_DEVIATION 8.2 • n=136 Participants
|
76.5 Years
STANDARD_DEVIATION 8.5 • n=271 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=135 Participants
|
73 Participants
n=136 Participants
|
154 Participants
n=271 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=135 Participants
|
63 Participants
n=136 Participants
|
117 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
10 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=135 Participants
|
122 Participants
n=136 Participants
|
248 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
13 Participants
n=271 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=271 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=135 Participants
|
127 Participants
n=136 Participants
|
258 Participants
n=271 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
9 Participants
n=271 Participants
|
|
Baseline BCVA letters scores (study eye)
|
60.2 letters
STANDARD_DEVIATION 12.1 • n=106 Participants • PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
|
61.3 letters
STANDARD_DEVIATION 10.8 • n=104 Participants • PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
|
60.8 letters
STANDARD_DEVIATION 11.4 • n=210 Participants • PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
|
|
Baseline CRT
|
443.7 μm
STANDARD_DEVIATION 120.0 • n=106 Participants • PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
|
448.3 μm
STANDARD_DEVIATION 133.1 • n=104 Participants • PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
|
446.0 μm
STANDARD_DEVIATION 126.4 • n=210 Participants • PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
|
PRIMARY outcome
Timeframe: From Week 16 to Week 104Population: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Change in BCVA as Measured by the ETDRS Letter Score
|
-2.1 Letters correctly read
Standard Deviation 11.4
|
-0.4 Letters correctly read
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: at Week 104Population: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline
|
93.4 Percentage
|
96.2 Percentage
|
SECONDARY outcome
Timeframe: from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52Population: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52
From baseline to Week 104
|
4.3 Letters
Standard Deviation 13.4
|
7.9 Letters
Standard Deviation 11.9
|
|
Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52
From baseline to Week 52
|
7.8 Letters
Standard Deviation 9.4
|
10.2 Letters
Standard Deviation 9.3
|
|
Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52
Week 16
|
66.7 Letters
Standard Deviation 13.0
|
69.6 Letters
Standard Deviation 11.6
|
|
Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52
From Week 16 to Week 52
|
1.3 Letters
Standard Deviation 6.4
|
2.0 Letters
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: At week 52Population: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline
|
100.0 Percentage
|
100.0 Percentage
|
SECONDARY outcome
Timeframe: At Week 52 and Week 104Population: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline
Week 52
|
19.8 Percentage
|
27.9 Percentage
|
|
Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline
Week 104
|
18.9 Percentage
|
22.1 Percentage
|
SECONDARY outcome
Timeframe: From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104Population: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
CRT were evaluated using spectral domain Optical coherence tomograph (OCT).
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Change in Central Retinal Thickness (CRT)
From baseline to Week 52
|
-164.9 μm
Standard Deviation 117.3
|
-167.1 μm
Standard Deviation 117.1
|
|
Change in Central Retinal Thickness (CRT)
From baseline to Week 104
|
-161.6 μm
Standard Deviation 135.6
|
-158.6 μm
Standard Deviation 125.1
|
|
Change in Central Retinal Thickness (CRT)
Week 16
|
321.4 μm
Standard Deviation 93.4
|
322.5 μm
Standard Deviation 104.0
|
|
Change in Central Retinal Thickness (CRT)
From Week 16 to Week 52
|
-28.5 μm
Standard Deviation 56.3
|
-28.7 μm
Standard Deviation 54.0
|
|
Change in Central Retinal Thickness (CRT)
From Week 16 to Week 104
|
-25.1 μm
Standard Deviation 68.9
|
-20.2 μm
Standard Deviation 70.0
|
SECONDARY outcome
Timeframe: At Week 52 and Week 104Population: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104
Week 52
|
7.1 injections
Standard Deviation 0.8
|
8.0 injections
Standard Deviation 0.2
|
|
Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104
Week 104
|
12.0 injections
Standard Deviation 2.3
|
13.0 injections
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early terminationPopulation: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Duration of Last Treatment Interval
|
11.5 Weeks
Standard Deviation 3.7
|
11.4 Weeks
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeksPopulation: PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation.
Outcome measures
| Measure |
Early-start T&E Arm
n=106 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=104 Participants
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
|---|---|---|
|
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
>16 weeks
|
4.7 percentage
|
1.9 percentage
|
|
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
<8 weeks
|
5.7 percentage
|
7.7 percentage
|
|
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
8 weeks
|
27.4 percentage
|
29.8 percentage
|
|
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
10 weeks
|
19.8 percentage
|
10.6 percentage
|
|
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
12 weeks
|
8.5 percentage
|
13.5 percentage
|
|
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
14 weeks
|
8.5 percentage
|
11.5 percentage
|
|
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
16 weeks
|
25.5 percentage
|
25.0 percentage
|
Adverse Events
Early-start T&E Arm
Serious events: 29 serious events
Other events: 93 other events
Deaths: 3 deaths
Late-start T&E Arm
Serious events: 35 serious events
Other events: 80 other events
Deaths: 4 deaths
Treated, But Not Randomized
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Early-start T&E Arm
n=135 participants at risk
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=136 participants at risk
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Treated, But Not Randomized
n=16 participants at risk
Participants were treated during the initiation phase, received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4 and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks)at Week 16, but were not randomized to a treatment arm after the initiation phase.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Atrioventricular block
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.74%
1/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Eye inflammation
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Visual impairment
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Eyelid cyst
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Constipation
|
0.74%
1/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Gastritis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
General disorders
Hernia
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
General disorders
Pyrexia
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Bronchitis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Cystitis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Influenza
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Pneumonia
|
2.2%
3/135 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
3.7%
5/136 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Sepsis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
2.2%
3/135 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Adenovirus infection
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid mesothelioma
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
12.5%
2/16 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Psychiatric disorders
Suicide attempt
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.74%
1/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
1.5%
2/136 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Haematoma
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Intermittent claudication
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Extremity necrosis
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
Other adverse events
| Measure |
Early-start T&E Arm
n=135 participants at risk
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T\&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Late-start T&E Arm
n=136 participants at risk
All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T\&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria.
|
Treated, But Not Randomized
n=16 participants at risk
Participants were treated during the initiation phase, received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4 and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks)at Week 16, but were not randomized to a treatment arm after the initiation phase.
|
|---|---|---|---|
|
Eye disorders
Blepharitis
|
1.5%
2/135 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
8.1%
11/136 • Number of events 25 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Cataract
|
6.7%
9/135 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
5.9%
8/136 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Cataract nuclear
|
1.5%
2/135 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
5.1%
7/136 • Number of events 16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Conjunctival haemorrhage
|
14.8%
20/135 • Number of events 26 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
13.2%
18/136 • Number of events 20 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Corneal erosion
|
3.7%
5/135 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
1.5%
2/136 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Dry eye
|
4.4%
6/135 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
8.1%
11/136 • Number of events 18 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Macular degeneration
|
4.4%
6/135 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
3.7%
5/136 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Punctate keratitis
|
7.4%
10/135 • Number of events 23 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
3.7%
5/136 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Retinal haemorrhage
|
3.0%
4/135 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
4.4%
6/136 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
12.5%
2/16 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Visual acuity reduced
|
15.6%
21/135 • Number of events 24 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
12.5%
17/136 • Number of events 19 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Visual impairment
|
5.9%
8/135 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
2.9%
4/136 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Vitreous floaters
|
5.9%
8/135 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
2.9%
4/136 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Vitreous adhesions
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Choroidal neovascularisation
|
5.2%
7/135 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
3.7%
5/136 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Retinal pigment epithelial tear
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
11.1%
15/135 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
10.3%
14/136 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Eye disorders
Macular fibrosis
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
4.4%
6/136 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
2.2%
3/136 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Influenza
|
8.1%
11/135 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
8.8%
12/136 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
18/135 • Number of events 21 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
12.5%
17/136 • Number of events 22 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/135 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/136 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
8/135 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
6.2%
1/16 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
|
Vascular disorders
Hypertension
|
9.6%
13/135 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
8.1%
11/136 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
0.00%
0/16 • Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.
Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER