Trial Outcomes & Findings for Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD) (NCT NCT00320788)
NCT ID: NCT00320788
Last Updated: 2012-03-01
Results Overview
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
Baseline and at Week 12
Results posted on
2012-03-01
Participant Flow
The study was conducted at 29 study sites in the United States. Recruitment period: May 2006 to April 2007.
A total of 301 participants were screened; 159 participants were randomized; 157 participants were included in both the Safety Analysis Set (SAF) and the Full Analysis Set (FAS) as all received study treatment, had baseline assessments and at least 1 post-baseline assessment.
Participant milestones
| Measure |
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
32
|
31
|
|
Overall Study
Participants Received Treatment (SAF)
|
32
|
32
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
26
|
26
|
29
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
3
|
5
|
5
|
Reasons for withdrawal
| Measure |
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
|
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Decision by the Sponsor
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Other
|
1
|
2
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
3
|
1
|
Baseline Characteristics
Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Aflibercept Injection 0.5mg q4
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
n=31 Participants
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
79.6 years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
78.5 years
STANDARD_DEVIATION 10.12 • n=7 Participants
|
74.9 years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
79.6 years
STANDARD_DEVIATION 8.91 • n=4 Participants
|
78.3 years
STANDARD_DEVIATION 5.97 • n=21 Participants
|
78.2 years
STANDARD_DEVIATION 8.25 • n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
0 • n=5 Participants
|
25 Participants
0 • n=7 Participants
|
20 Participants
0 • n=5 Participants
|
16 Participants
0 • n=4 Participants
|
20 Participants
0 • n=21 Participants
|
98 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
0 • n=5 Participants
|
7 Participants
0 • n=7 Participants
|
11 Participants
0 • n=5 Participants
|
15 Participants
0 • n=4 Participants
|
11 Participants
0 • n=21 Participants
|
59 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
0 • n=5 Participants
|
1 Participants
0 • n=7 Participants
|
2 Participants
0 • n=5 Participants
|
1 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
0 • n=5 Participants
|
31 Participants
0 • n=7 Participants
|
29 Participants
0 • n=5 Participants
|
30 Participants
0 • n=4 Participants
|
31 Participants
0 • n=21 Participants
|
153 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
1 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
0 • n=5 Participants
|
32 Participants
0 • n=7 Participants
|
30 Participants
0 • n=5 Participants
|
31 Participants
0 • n=4 Participants
|
31 Participants
0 • n=21 Participants
|
156 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=7 Participants
|
0 Participants
0 • n=5 Participants
|
0 Participants
0 • n=4 Participants
|
0 Participants
0 • n=21 Participants
|
0 Participants
n=10 Participants
|
|
Central Retinal/Lesion Thickness (CR/LT)
|
442.2 µm
STANDARD_DEVIATION 109.81 • n=5 Participants
|
442.6 µm
STANDARD_DEVIATION 136.60 • n=7 Participants
|
453.3 µm
STANDARD_DEVIATION 143.93 • n=5 Participants
|
447.0 µm
STANDARD_DEVIATION 119.11 • n=4 Participants
|
497.5 µm
STANDARD_DEVIATION 191.17 • n=21 Participants
|
456.4 µm
STANDARD_DEVIATION 142.41 • n=10 Participants
|
|
Best Corrected Visual Acuity (BCVA)
|
54.1 letters read
STANDARD_DEVIATION 13.77 • n=5 Participants
|
55.6 letters read
STANDARD_DEVIATION 11.75 • n=7 Participants
|
57.9 letters read
STANDARD_DEVIATION 12.02 • n=5 Participants
|
57.2 letters read
STANDARD_DEVIATION 10.47 • n=4 Participants
|
53.0 letters read
STANDARD_DEVIATION 14.52 • n=21 Participants
|
55.5 letters read
STANDARD_DEVIATION 12.57 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and at Week 12Population: Full Analysis Set (FAS) used for analysis, Last Observation Carried Forward (LOCF)
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
Outcome measures
| Measure |
Aflibercept Injection 0.5mg q4
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
n=31 Participants
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Total
n=157 Participants
|
|---|---|---|---|---|---|---|
|
Mean Change of CR/LT From Baseline at Week 12
|
-153.5 μm
Standard Deviation 113.30 • Interval 0.0 to 0.0
|
-75.6 μm
Standard Deviation 110.64 • Interval 0.0 to 0.0
|
-169.2 μm
Standard Deviation 138.46 • Interval 0.0 to 0.0
|
-56.3 μm
Standard Deviation 133.05 • Interval 0.0 to 0.0
|
-139.8 μm
Standard Deviation 228.59 • Interval 0.0 to 0.0
|
-118.8 μm
Standard Deviation 155.31 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and at Week 12Population: FAS used for analysis, LOCF
CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
Outcome measures
| Measure |
Aflibercept Injection 0.5mg q4
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
n=31 Participants
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Total
n=157 Participants
|
|---|---|---|---|---|---|---|
|
Mean Percent Change of CR/LT From Baseline at Week 12
|
-32.4 percent change
Standard Deviation 18.92 • Interval 0.0 to 0.0
|
-15.2 percent change
Standard Deviation 22.52 • Interval 0.0 to 0.0
|
-33.2 percent change
Standard Deviation 19.56 • Interval 0.0 to 0.0
|
-10.3 percent change
Standard Deviation 25.49 • Interval 0.0 to 0.0
|
-21.1 percent change
Standard Deviation 31.56 • Interval 0.0 to 0.0
|
-22.5 percent change
Standard Deviation 25.41 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and at week 12Population: FAS used for analysis, LOCF
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning
Outcome measures
| Measure |
Aflibercept Injection 0.5mg q4
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
n=31 Participants
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Total
n=157 Participants
|
|---|---|---|---|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12
|
8.8 letters read
Standard Deviation 9.20 • Interval 0.0 to 0.0
|
3.8 letters read
Standard Deviation 11.55 • Interval 0.0 to 0.0
|
8.3 letters read
Standard Deviation 10.14 • Interval 0.0 to 0.0
|
5.2 letters read
Standard Deviation 8.46 • Interval 0.0 to 0.0
|
2.6 letters read
Standard Deviation 8.72 • Interval 0.0 to 0.0
|
5.7 letters read
Standard Deviation 9.87 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: At Week 12Population: FAS used for analysis, LOCF
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning
Outcome measures
| Measure |
Aflibercept Injection 0.5mg q4
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
n=31 Participants
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Total
n=157 Participants
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12
|
18.8 percentage of participants
0 • Interval 0.0 to 0.0
|
21.9 percentage of participants
0 • Interval 0.0 to 0.0
|
25.8 percentage of participants
0 • Interval 0.0 to 0.0
|
16.1 percentage of participants
0 • Interval 0.0 to 0.0
|
9.7 percentage of participants
0 • Interval 0.0 to 0.0
|
18.5 percentage of participants
0 • Interval 0.0 to 0.0
|
POST_HOC outcome
Timeframe: Baseline and at Week 16Population: FAS used for analysis, LOCF
CR/LT measured in micrometers (µm); lower individual values represent better outcomes
Outcome measures
| Measure |
Aflibercept Injection 0.5mg q4
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
n=31 Participants
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Total
n=157 Participants
|
|---|---|---|---|---|---|---|
|
Mean Change of CR/LT From Baseline at Week 16
|
-163.3 µm
Standard Deviation 108.13 • Interval 0.0 to 0.0
|
-139.6 µm
Standard Deviation 126.41 • Interval 0.0 to 0.0
|
-182.7 µm
Standard Deviation 146.75 • Interval 0.0 to 0.0
|
-107.4 µm
Standard Deviation 112.22 • Interval 0.0 to 0.0
|
-208.6 µm
Standard Deviation 202.07 • Interval 0.0 to 0.0
|
-160.2 µm
Standard Deviation 145.34 • Interval 0.0 to 0.0
|
POST_HOC outcome
Timeframe: Baseline and at Week 16Population: FAS used for analysis, LOCF
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning
Outcome measures
| Measure |
Aflibercept Injection 0.5mg q4
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
n=32 Participants
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
n=31 Participants
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
n=31 Participants
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Total
n=157 Participants
|
|---|---|---|---|---|---|---|
|
Mean Change in BCVA as Measured by ETDRS From Baseline at Week 16
|
9.3 letters read
Standard Deviation 9.92 • Interval 0.0 to 0.0
|
5.6 letters read
Standard Deviation 12.24 • Interval 0.0 to 0.0
|
10.0 letters read
Standard Deviation 9.76 • Interval 0.0 to 0.0
|
4.3 letters read
Standard Deviation 10.01 • Interval 0.0 to 0.0
|
3.9 letters read
Standard Deviation 9.92 • Interval 0.0 to 0.0
|
6.6 letters read
Standard Deviation 10.60 • Interval 0.0 to 0.0
|
Adverse Events
Aflibercept Injection 0.5mg q4
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
Aflibercept Injection 0.5mg q12
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Aflibercept Injection 2.0mg q4
Serious events: 10 serious events
Other events: 27 other events
Deaths: 0 deaths
Aflibercept Injection 2.0mg q12
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Aflibercept Injection 4.0mg q12
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept Injection 0.5mg q4
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM MALIGNANT
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
DYSKINESIA OESOPHAGEAL
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
VOLVULUS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
General disorders
ASTHENIA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
GASTROENTERITIS
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
PNEUMONIA
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Injury, poisoning and procedural complications
FALL
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Injury, poisoning and procedural complications
SYNOVIAL RUPTURE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Renal and urinary disorders
STRESS INCONTINENCE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
CAROTID ARTERY OCCLUSION
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
DYSARTHRIA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
SPINAL CORD DISORDER
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Surgical and medical procedures
PILONIDAL SINUS REPAIR
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
UVEITIS
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
Other adverse events
| Measure |
Aflibercept Injection 0.5mg q4
Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 0.5mg q12
Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q4
Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
|
Aflibercept Injection 2.0mg q12
Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
Aflibercept Injection 4.0mg q12
Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
|
|---|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
SINUS HEADACHE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Psychiatric disorders
INSOMNIA
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
BLEPHARITIS
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
CATARACT
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
CATARACT NUCLEAR
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
CATARACT SUBCAPSULAR
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
CHOROIDAL NEOVASCULARISATION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
DETACHMENT OF RETINAL PIGMENT EPITHELIUM
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
DRY EYE
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
REFRACTION DISORDER
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
12.5%
4/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
RETINAL OEDEMA
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
RETINAL PIGMENT EPITHELIOPATHY
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
12.9%
4/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
VITREOUS DETACHMENT
|
12.5%
4/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
12.9%
4/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
VITREOUS FLOATERS
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
EYE INFLAMMATION
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
EYE IRRITATION
|
15.6%
5/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
EYE PAIN
|
15.6%
5/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
12.9%
4/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
LACRIMATION DECREASED
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
MACULAR DEGENERATION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
MACULOPATHY
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
PHOTOPSIA
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
PUNCTATE KERATITIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
RETINAL DEPIGMENTATION
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
SUBRETINAL FIBROSIS
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
VISION BLURRED
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Eye disorders
VISUAL DISTURBANCE
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
BRONCHITIS
|
15.6%
5/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Vascular disorders
HYPERTENSION
|
18.8%
6/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.6%
5/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Gastrointestinal disorders
NAUSEA
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
General disorders
CHEST PAIN
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
ANGINA PECTORIS
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Cardiac disorders
BRADYCARDIA
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Immune system disorders
SEASONAL ALLERGY
|
12.5%
4/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
CYSTITIS
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
PNEUMONIA
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
SINUSITIS
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
TOOTH ABSCESS
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
19.4%
6/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.7%
3/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
9.4%
3/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
19.4%
6/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Injury, poisoning and procedural complications
FALL
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Injury, poisoning and procedural complications
JOINT SPRAIN
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Investigations
BLOOD UREA INCREASED
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Metabolism and nutrition disorders
GOUT
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
12.5%
4/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
DEMENTIA ALZHEIMER'S TYPE
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.2%
2/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
|
Nervous system disorders
DIZZINESS
|
3.1%
1/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/32 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
6.5%
2/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
3.2%
1/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
0.00%
0/31 • Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.
Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After completion of the trial, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential or proprietary information from such communications. The sponsor cannot require other changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER