Trial Outcomes & Findings for Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT02250651)
NCT ID: NCT02250651
Last Updated: 2021-07-28
Results Overview
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
528 participants
Primary outcome timeframe
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
Results posted on
2021-07-28
Participant Flow
Participant milestones
| Measure |
Bimatoprost SR 15 μg
Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
Treatment Period 1 (Day 1 to Week 15)
STARTED
|
176
|
176
|
176
|
|
Treatment Period 1 (Day 1 to Week 15)
Received Sham or Bimatoprost SR
|
176
|
175
|
173
|
|
Treatment Period 1 (Day 1 to Week 15)
COMPLETED
|
172
|
170
|
165
|
|
Treatment Period 1 (Day 1 to Week 15)
NOT COMPLETED
|
4
|
6
|
11
|
|
Treatment Period 2 (Week 16 to Week 31)
STARTED
|
165
|
168
|
165
|
|
Treatment Period 2 (Week 16 to Week 31)
COMPLETED
|
159
|
162
|
160
|
|
Treatment Period 2 (Week 16 to Week 31)
NOT COMPLETED
|
6
|
6
|
5
|
|
Treatment Period 3 (Week 32 to Week 52)
STARTED
|
147
|
156
|
159
|
|
Treatment Period 3 (Week 32 to Week 52)
COMPLETED
|
138
|
152
|
154
|
|
Treatment Period 3 (Week 32 to Week 52)
NOT COMPLETED
|
9
|
4
|
5
|
Reasons for withdrawal
| Measure |
Bimatoprost SR 15 μg
Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
Treatment Period 1 (Day 1 to Week 15)
Adverse Event
|
0
|
2
|
2
|
|
Treatment Period 1 (Day 1 to Week 15)
Lost to Follow-up
|
1
|
0
|
0
|
|
Treatment Period 1 (Day 1 to Week 15)
Personal Reasons
|
2
|
3
|
5
|
|
Treatment Period 1 (Day 1 to Week 15)
Protocol Deviation
|
1
|
0
|
0
|
|
Treatment Period 1 (Day 1 to Week 15)
Reason not Specified
|
0
|
0
|
1
|
|
Treatment Period 1 (Day 1 to Week 15)
Randomized but not Treated
|
0
|
1
|
3
|
|
Treatment Period 2 (Week 16 to Week 31)
Adverse Event
|
4
|
1
|
0
|
|
Treatment Period 2 (Week 16 to Week 31)
Lost to Follow-up
|
0
|
0
|
3
|
|
Treatment Period 2 (Week 16 to Week 31)
Personal Reasons
|
2
|
3
|
2
|
|
Treatment Period 2 (Week 16 to Week 31)
Protocol Deviation
|
0
|
1
|
0
|
|
Treatment Period 2 (Week 16 to Week 31)
Reason not Specified
|
0
|
1
|
0
|
|
Treatment Period 3 (Week 32 to Week 52)
Adverse Event
|
4
|
1
|
1
|
|
Treatment Period 3 (Week 32 to Week 52)
Lost to Follow-up
|
1
|
2
|
1
|
|
Treatment Period 3 (Week 32 to Week 52)
Personal Reasons
|
2
|
0
|
2
|
|
Treatment Period 3 (Week 32 to Week 52)
Reason not Specified
|
2
|
1
|
1
|
Baseline Characteristics
The number analyzed is the number of participants with data available for IOP at Baseline.
Baseline characteristics by cohort
| Measure |
Bimatoprost SR 15 μg
n=176 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=176 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=176 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Total
n=528 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 10.7 • n=176 Participants
|
62.5 years
STANDARD_DEVIATION 12.7 • n=176 Participants
|
61.4 years
STANDARD_DEVIATION 12.4 • n=176 Participants
|
62.6 years
STANDARD_DEVIATION 12.0 • n=528 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=176 Participants
|
90 Participants
n=176 Participants
|
88 Participants
n=176 Participants
|
269 Participants
n=528 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=176 Participants
|
86 Participants
n=176 Participants
|
88 Participants
n=176 Participants
|
259 Participants
n=528 Participants
|
|
Race/Ethnicity, Customized
White
|
116 Participants
n=176 Participants
|
115 Participants
n=176 Participants
|
104 Participants
n=176 Participants
|
335 Participants
n=528 Participants
|
|
Race/Ethnicity, Customized
Black or African and American
|
19 Participants
n=176 Participants
|
20 Participants
n=176 Participants
|
36 Participants
n=176 Participants
|
75 Participants
n=528 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=176 Participants
|
11 Participants
n=176 Participants
|
13 Participants
n=176 Participants
|
30 Participants
n=528 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
27 Participants
n=176 Participants
|
22 Participants
n=176 Participants
|
21 Participants
n=176 Participants
|
70 Participants
n=528 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=176 Participants
|
8 Participants
n=176 Participants
|
2 Participants
n=176 Participants
|
18 Participants
n=528 Participants
|
|
Intraocular Pressure (IOP)
Hour 0
|
24.39 millimeters of mercury (mmHg)
n=176 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
24.28 millimeters of mercury (mmHg)
n=176 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
24.46 millimeters of mercury (mmHg)
n=175 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
24.38 millimeters of mercury (mmHg)
n=527 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
|
Intraocular Pressure (IOP)
Hour 2
|
23.41 millimeters of mercury (mmHg)
n=176 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
23.24 millimeters of mercury (mmHg)
n=175 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
23.43 millimeters of mercury (mmHg)
n=175 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
23.36 millimeters of mercury (mmHg)
n=526 Participants • The number analyzed is the number of participants with data available for IOP at Baseline.
|
PRIMARY outcome
Timeframe: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=176 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=176 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=176 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
Change from Baseline at Week 12, Hour 0
|
-6.47 millimeters of mercury (mmHg)
Standard Error 0.30
|
-6.18 millimeters of mercury (mmHg)
Standard Error 0.30
|
-6.11 millimeters of mercury (mmHg)
Standard Error 0.30
|
|
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
Change from Baseline at Week 12, Hour 2
|
-7.16 millimeters of mercury (mmHg)
Standard Error 0.28
|
-6.72 millimeters of mercury (mmHg)
Standard Error 0.28
|
-6.36 millimeters of mercury (mmHg)
Standard Error 0.29
|
PRIMARY outcome
Timeframe: Week 2 (Hour 0)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=170 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=172 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=172 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
IOP in the Study Eye at Week 2 (Hour 0)
|
16.74 mmHg
Standard Error 0.27
|
16.92 mmHg
Standard Error 0.27
|
17.50 mmHg
Standard Error 0.27
|
PRIMARY outcome
Timeframe: Week 2 (Hour 2)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=170 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=172 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=172 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
IOP in the Study Eye at Week 2 (Hour 2)
|
16.09 mmHg
Standard Error 0.25
|
16.48 mmHg
Standard Error 0.25
|
17.19 mmHg
Standard Error 0.25
|
PRIMARY outcome
Timeframe: Week 6 (Hour 0)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=172 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=171 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=168 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
IOP in the Study Eye at Week 6 (Hour 0)
|
17.05 mmHg
Standard Error 0.28
|
16.93 mmHg
Standard Error 0.28
|
17.51 mmHg
Standard Error 0.29
|
PRIMARY outcome
Timeframe: Week 6 (Hour 2)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=172 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=171 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=168 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
IOP in the Study Eye at Week 6 (Hour 2)
|
16.13 mmHg
Standard Error 0.26
|
16.53 mmHg
Standard Error 0.26
|
17.18 mmHg
Standard Error 0.27
|
PRIMARY outcome
Timeframe: Week 12 (Hour 0)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=168 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=169 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=166 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
IOP in the Study Eye at Week 12 (Hour 0)
|
17.39 mmHg
Standard Error 0.30
|
17.68 mmHg
Standard Error 0.30
|
17.75 mmHg
Standard Error 0.30
|
PRIMARY outcome
Timeframe: Week 12 (Hour 2)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=168 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=169 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=166 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
IOP in the Study Eye at Week 12 (Hour 2)
|
16.70 mmHg
Standard Error 0.28
|
17.15 mmHg
Standard Error 0.28
|
17.50 mmHg
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Bimatoprost SR 15 μg
n=176 Participants
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=176 Participants
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=176 Participants
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
Change From Baseline in IOP in the Study Eye
Change from Baseline at Week 6, Hour 2
|
-7.74 mmHg
Standard Error 0.26
|
-7.33 mmHg
Standard Error 0.26
|
-6.69 mmHg
Standard Error 0.27
|
|
Change From Baseline in IOP in the Study Eye
Change from Baseline at Week 2, Hour 0
|
-7.12 mmHg
Standard Error 0.27
|
-6.94 mmHg
Standard Error 0.27
|
-6.36 mmHg
Standard Error 0.27
|
|
Change From Baseline in IOP in the Study Eye
Change from Baseline at Week 2, Hour 2
|
-7.77 mmHg
Standard Error 0.25
|
-7.38 mmHg
Standard Error 0.25
|
-6.67 mmHg
Standard Error 0.25
|
|
Change From Baseline in IOP in the Study Eye
Change from Baseline at Week 6, Hour 0
|
-6.81 mmHg
Standard Error 0.28
|
-6.93 mmHg
Standard Error 0.28
|
-6.35 mmHg
Standard Error 0.29
|
Adverse Events
Bimatoprost SR 15 μg
Serious events: 36 serious events
Other events: 133 other events
Deaths: 1 deaths
Bimatoprost SR 10 μg
Serious events: 22 serious events
Other events: 103 other events
Deaths: 0 deaths
Timolol 0.5%: Comparator
Serious events: 16 serious events
Other events: 72 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Bimatoprost SR 15 μg
n=176 participants at risk
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=175 participants at risk
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=173 participants at risk
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
3/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Atrial fibrillation
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Myocardial infarction
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Angina pectoris
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Angina unstable
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Coronary artery disease
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Gastrointestinal disorders
Ascites
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.2%
2/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
General disorders
Death
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Immune system disorders
Sarcoidosis
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Infections and infestations
Pneumonia
|
1.7%
3/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Infections and infestations
Appendicitis
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.1%
2/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.4%
2/85 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/85 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.1%
1/88 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
2/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Natural killer-cell leukaemia
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Nervous system disorders
Encephalopathy
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.1%
2/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Psychiatric disorders
Depression
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/91 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.1%
1/90 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/85 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/91 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.1%
1/90 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/85 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Corneal endothelial cell loss
|
5.1%
9/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.7%
3/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Corneal oedema
|
1.1%
2/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Macular oedema
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Injury, poisoning and procedural complications
Product administered at inappropriate site
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Pterygium
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Corneal decompensation
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Visual impairment
|
0.00%
0/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.57%
1/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Retinal tear
|
0.57%
1/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
Other adverse events
| Measure |
Bimatoprost SR 15 μg
n=176 participants at risk
Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Bimatoprost SR 10 μg
n=175 participants at risk
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Timolol 0.5%: Comparator
n=173 participants at risk
Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
41.5%
73/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
27.4%
48/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
11.6%
20/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Corneal endothelial cell loss
|
21.6%
38/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
6.9%
12/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.2%
2/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Eye pain
|
13.1%
23/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
6.9%
12/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
5.2%
9/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Corneal oedema
|
11.9%
21/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
2.9%
5/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Foreign body sensation in eyes
|
10.8%
19/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
10.3%
18/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.2%
2/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Dry eye
|
10.2%
18/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
6.9%
12/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
4.0%
7/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Conjunctival haemorrhage
|
9.7%
17/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
11.4%
20/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
8.7%
15/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Punctate keratitis
|
8.0%
14/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
5.7%
10/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
4.6%
8/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Photophobia
|
7.4%
13/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
7.4%
13/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Eye irritation
|
7.4%
13/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
5.7%
10/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
5.2%
9/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Anterior chamber cell
|
7.4%
13/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
3.4%
6/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Ocular discomfort
|
6.2%
11/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
1.7%
3/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Iritis
|
5.1%
9/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
4.6%
8/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.00%
0/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Lacrimation increased
|
5.1%
9/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
4.0%
7/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Vision blurred
|
4.0%
7/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
6.3%
11/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
0.58%
1/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Eye disorders
Blepharitis
|
4.0%
7/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
5.7%
10/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
2.9%
5/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
9/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
6.9%
12/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
8.1%
14/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
|
Investigations
Intraocular pressure increased
|
9.7%
17/176 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
8.6%
15/175 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
3.5%
6/173 • First dose of study drug to last visit (Up to approximately 20 months)
All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye \[fellow-eye\]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER