Trial Outcomes & Findings for Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (NCT NCT05381948)
NCT ID: NCT05381948
Last Updated: 2025-10-15
Results Overview
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
Baseline (Day 1) and Weeks 28 and 32
Results posted on
2025-10-15
Participant Flow
This Phase 2 prospective, randomized, double-masked study was conducted in previously treated subjects with wet age-related macular degeneration (wAMD) at 39 sites in the United States between 30 June 2022 and 24 April 2024.
This study consists of a screening period (up to 14 days) and treatment period (56 weeks). A total of 161 subjects were randomized in the study.
Participant milestones
| Measure |
Aflibercept 2 mg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
54
|
|
Overall Study
COMPLETED
|
52
|
47
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
2
|
Reasons for withdrawal
| Measure |
Aflibercept 2 mg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|
|
Overall Study
Adverse Event: Ocular - Study Eye
|
0
|
1
|
0
|
|
Overall Study
Adverse Event: Non-ocular
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
2
|
0
|
|
Overall Study
Discontinued study without receiving study drug
|
0
|
0
|
1
|
Baseline Characteristics
Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
Baseline characteristics by cohort
| Measure |
Aflibercept 2 mg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.9 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
76.4 years
STANDARD_DEVIATION 6.66 • n=7 Participants
|
75.4 years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
75.9 years
STANDARD_DEVIATION 7.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Weeks 28 and 32Population: The Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study treatment.
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Outcome measures
| Measure |
Aflibercept 2 mg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32
|
1.17 score on a scale
Standard Error 0.830
|
1.05 score on a scale
Standard Error 0.866
|
0.87 score on a scale
Standard Error 0.841
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at baseline and specific timepoints are reported.
The BCVA was measured according to the standard procedure originally developed for ETDRS. The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Outcome measures
| Measure |
Aflibercept 2 mg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity up to Week 56
Baseline (Day 1)
|
73.4 score on a scale
Standard Deviation 9.48
|
73.9 score on a scale
Standard Deviation 7.90
|
74.9 score on a scale
Standard Deviation 7.68
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Best Corrected Visual Acuity up to Week 56
Week 32
|
1.6 score on a scale
Standard Deviation 6.81
|
1.0 score on a scale
Standard Deviation 6.45
|
0.8 score on a scale
Standard Deviation 5.22
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Best Corrected Visual Acuity up to Week 56
Week 56
|
1.1 score on a scale
Standard Deviation 8.55
|
0.3 score on a scale
Standard Deviation 8.10
|
-1.9 score on a scale
Standard Deviation 7.83
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at baseline and specific timepoints are reported.
The BCVA was measured according to the standard procedure originally developed for ETDRS. The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Outcome measures
| Measure |
Aflibercept 2 mg
n=53 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=48 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 32: >=5 BCVA Letter Gain
|
34.0 percentage of subjects
|
25.0 percentage of subjects
|
21.2 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 32: >=5 BCVA Letter Loss
|
13.2 percentage of subjects
|
20.8 percentage of subjects
|
11.5 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 32: >=10 BCVA Letter Gain
|
5.7 percentage of subjects
|
10.4 percentage of subjects
|
5.8 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 32: >=10 BCVA Letter Loss
|
5.7 percentage of subjects
|
6.3 percentage of subjects
|
3.8 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 32: >=15 BCVA Letter Gain
|
1.9 percentage of subjects
|
2.1 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 32: >=15 BCVA Letter Loss
|
1.9 percentage of subjects
|
0 percentage of subjects
|
1.9 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 56: >=5 BCVA Letter Gain
|
32.7 percentage of subjects
|
23.4 percentage of subjects
|
15.4 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 56: >=5 BCVA Letter Loss
|
23.1 percentage of subjects
|
23.4 percentage of subjects
|
32.7 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 56: >=10 BCVA Letter Gain
|
17.3 percentage of subjects
|
12.8 percentage of subjects
|
3.8 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 56: >=10 BCVA Letter Loss
|
11.5 percentage of subjects
|
10.6 percentage of subjects
|
13.5 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 56: >=15 BCVA Letter Gain
|
1.9 percentage of subjects
|
4.3 percentage of subjects
|
0 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Week 56: >=15 BCVA Letter Loss
|
7.7 percentage of subjects
|
4.3 percentage of subjects
|
3.8 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at baseline and specific timepoints are reported.
Supplemental therapy was any unscheduled injection of aflibercept, whether or not a subject had met rescue criteria. For the aflibercept arm, any aflibercept injection following Week 8 which did not occur at Weeks 16, 24, 32, 40, 48, or 56, was supplemental therapy. For either of the EYP-1901 arms, any aflibercept injection following the Week 8 visit was supplemental therapy.
Outcome measures
| Measure |
Aflibercept 2 mg
n=53 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=48 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56
Week 32
|
94.3 percentage of subjects
|
62.5 percentage of subjects
|
63.5 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56
Week 56
|
82.7 percentage of subjects
|
42.6 percentage of subjects
|
46.2 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 8 to Week 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects received study treatment administration at Week 8 are reported.
Time to first supplemental aflibercept injection following Week 8 study treatment was defined as the date of the first supplemental aflibercept injection minus the date of the Week 8 study treatment administration, divided by 7 days per week. Subjects who did not receive any supplemental aflibercept injection following study treatment administration at Week 8 were censored at their date of last visit (those who completed) or date of last contact (those who discontinued the study early).
Outcome measures
| Measure |
Aflibercept 2 mg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8
|
37.00 week
Interval 20.14 to
The upper limit of the 95% confidence interval for the median was not available due to an insufficient number of observed events (ie, the first supplemental aflibercept injections) occurring after the median time point.
|
40.79 week
Interval 20.0 to
The upper limit of the 95% confidence interval for the median was not available due to an insufficient number of observed events (ie, the first supplemental aflibercept injections) occurring after the median time point.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment.
Normalized number of aflibercept injections including loading dose was calculated as (number of aflibercept injections received plus all loading doses received) / (time within study period in months), multiplied by 6 months (Week 32) or 12 months (Week 56).
Outcome measures
| Measure |
Aflibercept 2 mg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose)
Week 32
|
3.23 normalized no. of aflibercept injections
Standard Deviation 0.357
|
2.06 normalized no. of aflibercept injections
Standard Deviation 0.583
|
2.13 normalized no. of aflibercept injections
Standard Deviation 0.747
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose)
Week 56
|
6.33 normalized no. of aflibercept injections
Standard Deviation 0.754
|
3.45 normalized no. of aflibercept injections
Standard Deviation 1.738
|
3.36 normalized no. of aflibercept injections
Standard Deviation 1.854
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at baseline and specific timepoints are reported.
The SD-OCT assessments in study eye was taken by a study-certified OCT technician according to the standardized procedures described in the Study Manual. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Outcome measures
| Measure |
Aflibercept 2 mg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56
Baseline (Day 1)
|
265.7 micron
Standard Deviation 39.86
|
264.5 micron
Standard Deviation 40.26
|
262.9 micron
Standard Deviation 34.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56
Week 32
|
5.4 micron
Standard Deviation 44.52
|
17.8 micron
Standard Deviation 42.27
|
10.6 micron
Standard Deviation 38.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56
Week 56
|
8.1 micron
Standard Deviation 58.33
|
12.2 micron
Standard Deviation 49.83
|
16.7 micron
Standard Deviation 51.98
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at baseline and specific timepoints are reported.
The SD-OCT assessments in study eye was taken by a study-certified OCT technician according to the standardized procedures described in the Study Manual. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Outcome measures
| Measure |
Aflibercept 2 mg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56
Baseline (Day 1)
|
46.87 micron
Standard Deviation 27.753
|
49.84 micron
Standard Deviation 32.786
|
50.71 micron
Standard Deviation 28.507
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56
Week 32
|
33.05 micron
Standard Deviation 62.358
|
18.75 micron
Standard Deviation 48.197
|
10.68 micron
Standard Deviation 37.686
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56
Week 56
|
22.87 micron
Standard Deviation 69.509
|
39.50 micron
Standard Deviation 62.183
|
5.95 micron
Standard Deviation 38.866
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at specific timepoints are reported.
The percentage of subjects with no detectable intraretinal fluid/cysts in the central subfield were summarized by scheduled visit and for any time post-baseline visits. Intraretinal fluid was assessed for the categories 'Absent', 'Present, not clinically significant', 'Present, clinically significant' and 'Not Done'. If intraretinal fluid assessment at any scheduled visit fell under the category 'Absent or Present, not clinically significant', then it was considered as no detectable intraretinal fluid in that scheduled visit.
Outcome measures
| Measure |
Aflibercept 2 mg
n=53 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=48 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56
Week 32
|
62.3 percentage of subjects
|
52.1 percentage of subjects
|
51.9 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56
Week 56
|
59.6 percentage of subjects
|
59.6 percentage of subjects
|
51.9 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at baseline and specific timepoints are reported.
The total lesion area was defined as the active vascular component \[classic and occult choroidal neovascularization (CNV)\] and the non-vascular/fibrotic component (fibrosis, serous pigment epithelial detachment, elevated blocking hemorrhage or hyperplastic pigment). Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Outcome measures
| Measure |
Aflibercept 2 mg
n=32 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=26 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56
Baseline (Day 1)
|
5.06884 millimeter square (mm^2)
Standard Deviation 4.547571
|
5.48285 millimeter square (mm^2)
Standard Deviation 5.488682
|
4.82169 millimeter square (mm^2)
Standard Deviation 4.325932
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56
Week 32
|
1.24141 millimeter square (mm^2)
Standard Deviation 2.862256
|
1.07111 millimeter square (mm^2)
Standard Deviation 2.626369
|
1.13971 millimeter square (mm^2)
Standard Deviation 2.024426
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56
Week 56
|
1.56516 millimeter square (mm^2)
Standard Deviation 3.226403
|
1.84557 millimeter square (mm^2)
Standard Deviation 4.174053
|
2.22914 millimeter square (mm^2)
Standard Deviation 3.696873
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 32 and 56Population: The FAS included all randomized subjects who received at least 1 dose of study treatment. Only subjects analyzed at baseline and specific timepoints are reported.
The total CNV area included the measured area of classic and occult components. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Outcome measures
| Measure |
Aflibercept 2 mg
n=32 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=26 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56
Baseline (Day 1)
|
5.06 mm^2
Standard Deviation 4.551
|
5.44 mm^2
Standard Deviation 5.531
|
4.77 mm^2
Standard Deviation 4.322
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56
Week 32
|
1.15 mm^2
Standard Deviation 2.968
|
1.10 mm^2
Standard Deviation 2.674
|
1.19 mm^2
Standard Deviation 2.033
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56
Week 56
|
1.46 mm^2
Standard Deviation 3.354
|
1.14 mm^2
Standard Deviation 5.345
|
2.31 mm^2
Standard Deviation 3.656
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 56Population: The Pharmacokinetic (PK) set included all subjects in the safety set for whom at least 1 evaluable plasma or aqueous humor (AH) PK sample was available. No subjects were exposed to EYP-1901 in 'Aflibercept 2 mg' reporting group.
Blood samples were collected at the study visits to determine the EYP-1901 and its main metabolite concentrations.
Outcome measures
| Measure |
Aflibercept 2 mg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 8 - EYP-1901 concentration
|
—
|
0.000 picogram per milliliter
Standard Deviation 0.0000
|
0.000 picogram per milliliter
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 8 - metabolite concentration
|
—
|
0.00 picogram per milliliter
Standard Deviation 0.00
|
0.00 picogram per milliliter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 20 - EYP-1901 concentration
|
—
|
23.206 picogram per milliliter
Standard Deviation 8.8871
|
27.121 picogram per milliliter
Standard Deviation 10.0821
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 20 - metabolite concentration
|
—
|
1.01 picogram per milliliter
Standard Deviation 2.27
|
2.46 picogram per milliliter
Standard Deviation 3.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 32 - EYP-1901 concentration
|
—
|
14.333 picogram per milliliter
Standard Deviation 6.1098
|
19.335 picogram per milliliter
Standard Deviation 7.3783
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 32 - metabolite concentration
|
—
|
0.00 picogram per milliliter
Standard Deviation 0.00
|
0.598 picogram per milliliter
Standard Deviation 2.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 44 - EYP-1901 concentration
|
—
|
10.292 picogram per milliliter
Standard Deviation 5.2086
|
14.180 picogram per milliliter
Standard Deviation 4.9819
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 44 - metabolite concentration
|
—
|
0.00 picogram per milliliter
Standard Deviation 0.00
|
0.485 picogram per milliliter
Standard Deviation 1.69
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 56 - EYP-1901 concentration
|
—
|
7.733 picogram per milliliter
Standard Deviation 4.9684
|
10.392 picogram per milliliter
Standard Deviation 5.2315
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Week 56 - metabolite concentration
|
—
|
0.00 picogram per milliliter
Standard Deviation 0.00
|
0.121 picogram per milliliter
Standard Deviation 0.867
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 32Population: The PK set included all subjects in the safety set for whom at least 1 evaluable plasma or AH PK sample was available. No subjects were exposed to EYP-1901 in 'Aflibercept 2 mg' reporting group.
The AH samples were collected at the study visits to determine the EYP-1901 and its main metabolite concentrations.
Outcome measures
| Measure |
Aflibercept 2 mg
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=48 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
Week 8 - EYP-1901 concentration
|
—
|
0.000 nanogram per milliliter
Standard Deviation 0.0000
|
0.000 nanogram per milliliter
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
Week 8 - metabolite concentration
|
—
|
0.00 nanogram per milliliter
Standard Deviation 0.00
|
0.00 nanogram per milliliter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
Week 20 - EYP-1901 concentration
|
—
|
17.426 nanogram per milliliter
Standard Deviation 13.7143
|
25.066 nanogram per milliliter
Standard Deviation 18.8594
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
Week 20 - metabolite concentration
|
—
|
0.00 nanogram per milliliter
Standard Deviation 0.00
|
0.00 nanogram per milliliter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
Week 32 - EYP-1901 concentration
|
—
|
11.890 nanogram per milliliter
Standard Deviation 10.8436
|
19.813 nanogram per milliliter
Standard Deviation 15.0833
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
Week 32 - metabolite concentration
|
—
|
0.00 nanogram per milliliter
Standard Deviation 0.00
|
0.00 nanogram per milliliter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the study drug administration (Day 1) up to end of the study, approximately 56 weeks.Population: The Safety analysis set included all subjects who received at least 1 dose of study treatment.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. An serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment. administration.
Outcome measures
| Measure |
Aflibercept 2 mg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg
n=54 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
n=50 Participants
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
n=50 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
n=52 Participants
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
n=52 Participants
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56
any TEAEs
|
30 Participants
|
21 Participants
|
40 Participants
|
30 Participants
|
11 Participants
|
28 Participants
|
30 Participants
|
20 Participants
|
39 Participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56
any Serious TEAEs
|
2 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
9 Participants
|
Adverse Events
Aflibercept 2 mg - Study Eye
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Aflibercept 2 mg - Fellow Eye
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Aflibercept 2 mg - Systemic
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
EYP-1901 2060 mcg - Study Eye
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
EYP-1901 2060 mcg - Fellow Eye
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
EYP-1901 2060 mcg - Systemic
Serious events: 6 serious events
Other events: 28 other events
Deaths: 2 deaths
EYP-1901 3090 mcg - Study Eye
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
EYP-1901 3090 mcg - Fellow Eye
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
EYP-1901 3090 mcg - Systemic
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept 2 mg - Study Eye
n=54 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
Aflibercept 2 mg - Fellow Eye
n=54 participants at risk
No study treatment administered in fellow eye.
|
Aflibercept 2 mg - Systemic
n=54 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
n=50 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
n=50 participants at risk
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
n=50 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
n=52 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
n=52 participants at risk
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
n=52 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Non-infectious endophthalmitis
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Retinal detachment
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Retinal tear
|
1.9%
1/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Vitritis
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Endophthalmitis
|
3.7%
2/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastric infection
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Aflibercept 2 mg - Study Eye
n=54 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
Aflibercept 2 mg - Fellow Eye
n=54 participants at risk
No study treatment administered in fellow eye.
|
Aflibercept 2 mg - Systemic
n=54 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and sham injection at Week 8 and then aflibercept 2 mg intravitreal injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Study Eye
n=50 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 2060 mcg - Fellow Eye
n=50 participants at risk
No study treatment administered in fellow eye.
|
EYP-1901 2060 mcg - Systemic
n=50 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 2060 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Study Eye
n=52 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
EYP-1901 3090 mcg - Fellow Eye
n=52 participants at risk
No study treatment administered in fellow eye.
|
EYP-1901 3090 mcg - Systemic
n=52 participants at risk
Subjects received aflibercept 2 mg intravitreal injection on Day 1 and at Week 4 followed by intravitreal injection of aflibercept 2 mg and EYP-1901 3090 mcg injection at Week 8 and then intravitreal sham injection once every 8 weeks up to Week 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
8.0%
4/50 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Blepharitis
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Cataract
|
9.3%
5/54 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.7%
2/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
8.0%
4/50 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
9.6%
5/52 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
9.6%
5/52 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
7.4%
4/54 • Number of events 8 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
12.0%
6/50 • Number of events 7 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
6.0%
3/50 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Dry age-related macular degeneration
|
5.6%
3/54 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.7%
2/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Eye pain
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Macular oedema
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.6%
3/54 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Retinal haemorrhage
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.6%
3/54 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
11.5%
6/52 • Number of events 6 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Retinal oedema
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
8.0%
4/50 • Number of events 7 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Subretinal fluid
|
7.4%
4/54 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
12.0%
6/50 • Number of events 11 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
5.6%
3/54 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.7%
2/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
15.4%
8/52 • Number of events 8 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Vitreous detachment
|
5.6%
3/54 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
6.0%
3/50 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Vitreous floaters
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
11.5%
6/52 • Number of events 6 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
8.0%
4/50 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
7.7%
4/52 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
13.0%
7/54 • Number of events 7 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
10.0%
5/50 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
9.6%
5/52 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Endophthalmitis
|
3.7%
2/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
7.4%
4/54 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
2.0%
1/50 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
7.7%
4/52 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.6%
3/54 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.6%
3/54 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
10.0%
5/50 • Number of events 8 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
15.4%
8/52 • Number of events 8 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.6%
3/54 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
6.0%
3/50 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
7.7%
4/52 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.6%
3/54 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Investigations
Intraocular pressure increased
|
3.7%
2/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.7%
2/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
6.0%
3/50 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
8.0%
4/50 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
3.8%
2/52 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.6%
3/54 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/52 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
1.9%
1/54 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
5.8%
3/52 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/54 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
7.4%
4/54 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/50 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
4.0%
2/50 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
0.00%
0/52 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
13.5%
7/52 • Number of events 7 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
The Safety analysis set included all subjects who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place